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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

- Read across from Mixture of terphenyls and quarterphenyls; Key study: skin irritation (in vivo; OECD 405; New Zealand White rabbits; occlusive): not irritating;

- Read across from Mixture of terphenyls; Supporting study: skin irritation (in vivo; FIFRA, TSCA; New Zealand White rabbits; semiocclusive): not irritating;

- Read across from Mixture of terphenyls and quarterphenyls; Key study: eye irritation (in vivo; OECD 405; New Zealand White rabbits): not irritating;

- Read across from Mixture of terphenyls; Supporting study: eye irritation (in vivo; FIFRA, TSCA; New Zealand White rabbits): not irritating;

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
In this justification, the read-across (bridging) concept is applied, based on the chemical structure of the potential analogues, their toxicokinetic behaviour and other available (eco-)toxicological data.

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance Reaction mass of m-terphenyl and o-terphenyl and the source substance terphenyl (containing mainly m-terphenyl, o-terphenyl and only little p-terphenyl as well as a low percentage of quarterphenyls) used in this study belong to the group of closely related aromatic hydrocarbons. Also known as diphenylbenzenes or triphenyls, they consist of a central benzene ring substituted with two phenyl groups. Obviously, the contained isomers are only different to a minor extent. Moreover, all isomers have common functional group(s). In addition, they were simulated to have the same breakdown products using the In vivo rat metabolism simulator and the Rat liver S9 metabolism simulator (OECD QSAR Toolbox v4.2).
Therefore, both substances are expected to follow the same toxicokinetic pattern.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)

source substance:
Mixture of terphenyls (ca. 60 %; mainly m- and o-terphenyls and only a minor content of p-terphenyl) and quarterphenyls (ca. 35 %)
structural formula: C18H14 and C24H18
The terphenyl substance consists of three constituents, each with their own Smiles notation and structural formula:
o-terphenyl: c(c(c(cccc1)c1)ccc2)(c(cccc3)c3)c2
m-terphenyl: c(c(cccc1)c1)(cccc2c(cccc3)c3)c2
p-terphenyl: c(c(cccc1)c1)(ccc(c(cccc2)c2)c3)c3
The quarterphenyls:
ortho-/ortho-:c1cccc(c1c1ccccc1)c1ccccc1c1ccccc1
ortho-/meta-: c1c(cccc1c1ccccc1c1ccccc1)c1ccccc1
ortho-/para-: c1cc(ccc1c1ccccc1)c1ccccc1c1ccccc1
meta-/meta-: c1c(cccc1c1cccc(c1)c1ccccc1)c1ccccc1
meta-/para-: c1cc(ccc1c1ccccc1)c1cccc(c1)c1ccccc1
para-/para-: c1cc(ccc1c1ccccc1)c1ccc(cc1)c1ccccc1
CAS 26140-60-3
EC No 247-477-3
purity: not specified

target substance:
Reaction mass of m-terphenyl and o-terphenyl (100 % m- and o-terphenyl)
structural formula: C18H14
The substance consists of two constituents, each with their own Smiles notation and structural formula:
o-terphenyl: c(c(c(cccc1)c1)ccc2)(c(cccc3)c3)c2
m-terphenyl: c(c(cccc1)c1)(cccc2c(cccc3)c3)c2
CAS -
EC No 904-797-4
purity: ≥ 90 - ≤ 100 % (w/w)

3. ANALOGUE APPROACH JUSTIFICATION
Reaction mass of m-terphenyl and o-terphenyl and Mixture of terphenyls (ca. 60 %) and quarterphenyls (ca. 35 %) belong to the group of closely related aromatic hydrocarbons. Terphenyls, also known as diphenylbenzenes or triphenyls, consist of a central benzene ring substituted with two phenyl groups.

Both chemicals are expected to be metabolised similarly building similar metabolites (“common breakdown product").
The similar findings (refer to data matrix outlined below) for both substances support the conclusion that similar molecules will be formed from both substances when applied systemically. In consequence, Mixture of terphenyls and quarterphenyls may perfectly serve as read-across substance for Reaction mass of m-terphenyl and o-terphenyl and vice versa. So, the available data on Mixture of terphenyls and quarterphenyls can be used to cover all systemic endpoints currently lacking from Reaction mass of m-terphenyl and o-terphenyl, making further testing obsolete.

4. DATA MATRIX
There is mainly physico-chemical data available on the toxicological properties of Reaction mass of m-terphenyl and o-terphenyl. Data on Mixture of terphenyls and quarterphenyls covers among others the toxicokinetic, acute toxicity, irritation / corrosion and genetic mutation in vitro endpoint. The identification and discussion of common properties will be based on available data including toxicological and physicochemical data.
The physical state of the two substances is solid (Reaction Mass of m-terphenyl and o-terphenyl is a cream coloured solid block at room temperature; Mixture of terphenyls and quarterphenyls is a soft solid at room temperature, melting to a yellow liquid). Their melting point lies at 32 °C and 145 °C; their boiling point at 355°C and 343°C. Furthermore, their density is quite similar (1.11 x 10E3 kg/m3 at 20.0 ± 0.5 ºC and 1.133 x 10E3 kg/m3 at 25 ºC) and the vapour pressure is also in the same range (1.8 x 10E-2 Pa at 25 °C (corresponding to 1.7765 x 10E-7 atmosphere) and 1.6x10E-5 to 3.0x10E-14 atmosphere; the estimated vapour pressure of the o-, m- and p-terphenyls ranged from 4.3 x 10E-7 to 8.0 x 10E-10 atmosphere).
The available data for the following physico-chemical properties, which are relevant for absorption into living organisms, are very similar. Both substances are medium sized molecules with a molecular weight of 230.31 (Reaction mass of m-terphenyl and o-terphenyl) resp. 230 and 306 (terphenyls and quarterphenyls)), they are both insoluble and slightly soluble in water (Less than 1.0 x 10E-4 g/L of solution at 20.0 ± 0.5 °C (Reaction mass of m-terphenyl and o-terphenyl) and 0.151 mg/L at 25°C (Mixture of terphenyls and quarterphenyls)), respectively. Moreover, they have a rather high logPow (3.01 to 5.94 (Reaction mass of m-terphenyl and o-terphenyl) and 5.86 at 22°C (Mixture of terphenyls and quarterphenyls)). Both chemicals are not readily biodegradable and they are not expected to be hydrolysed due to lack of functional groups. For Reaction mass of m-terphenyl and o-terphenyl a QSAR calculation has been performed for the Bioconcentration factor (BCF). For both - m-terphenyl and o-terphenyl - a BCF of 2041 L/kg wet-wt (3.31 log BCF) was predicted. Mixture of terphenyls and quarterphenyls has a low potential for bioaccumulation in aquatic organisms.

There is only data available for the target substance Reaction mass of m-terphenyl and o-terphenyl for the following toxicological endpoints: Repeated dose toxicity oral and Toxicity to reproduction (fertility / developmental toxicity).
Moreover, there is data available for the Read Across substance Mixture of terphenyls and quarterphenyls for the following endpoints: Acute toxicity oral, Acute toxicity dermal, Skin irritation / corrosion, Eye irritation /corrosion, Genetic toxicity in vitro.
The Read Across substance Mixture or terphenyls and quarterphenyls has been shown to be not acutely toxic and not irritating to the skin or the eyes. In addition, the Read Across substance has been shown to be not mutagenic. For Reaction mass of m-terphenyl and o-terphenyl a NOAEL of 100 mg/kg bw was derived for the endpoint Repeated dose toxicity oral and for reproduction / developmental toxicity, based on effects around parturition at 300 mg/kg/day.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
8
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Intact and abraded skin
Remarks:
48 h value was not evaluted.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Intact skin
Remarks:
48 h value was not evaluted.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.13
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: Abraded skin
Remarks:
48 h value was not evaluted.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: Intact and abraded skin
Remarks:
48 h value was not evaluted.
Irritant / corrosive response data:
All skin irritation had subsided by the tenth day after test material administration. Defatting of the skin on all four exposed sites occurred in one animal on the tenth day after exposure. No signs of systemic toxicity were observed.

The daily individual, daily, mean, and 24- and 72 hour average Draize scores for the six animals are summarized below.

The Primary Irritation Index for this group of animals is 0.1 on a scale of 0.0 to 8.0. All skin irritation had subsided by the tenth day after test material administration. Defatting of the skin on all four exposed sites occurred in one animal on the tenth day after exposure. No signs of systemic toxicity were observed.

Table 1
Primary Skin Irritation to Rabbits Individual Irritation Scores

Animal Number

Period (Days)

ERYTHEMA

EDEMA

RFI

LBI

LFA

RBA

RFI

LBI

LFA

RBA

01M01

1

0

0

0

0

0

0

0

0

01M02

1

0

0

0

0

0

0

0

0

01M03

1

V

0

0

0

0

0

0

01F01

1

0

0

0

0

0

0

0

0

01F02

1

0

0

0

0

0

0

0

0

01F03

1

0

0

0

1

0

0

0

0

01M01

3

1

1

1

1

0

0

0

0

01M02

3

0

0

0

0

0

0

0

0

01M03

3

0

0

0

0

0

0

0

0

01F01

3

0

0

0

0

0

0

0

0

01F02

3

0

0

0

0

0

0

0

0

01F03

3

0

0

0

0

0

0

0

0

01M01

7

1

1

1

1

0

0

0

0

01M01

10

0

0

0

0

0

0

0

0

RFI - Right Front Intact Patch

RBA - Right Back Abraded Patch

LBI - Left Back Intact Patch

LFA - Left Front Abraded Patch

Primary skin irritation score summary:

Period (days)

Erythema

Edema

Irritation score

Intact

Abraded

Mean

Intact

Abraded

Mean

1

0.0

0.1

0.0

0.0

0.0

0.0

0.0

3

0.2

0.2

0.2

0.0

0.0

0.0

0.2

Interpretation of results:
not irritating
Conclusions:
The key study for skin irritation/corrosion is a K1 GLP study performed similar to OECD guideline 404, in which the Draize scoring system is used. New Zealand White rabbits were exposed to 0.5 g of the read across test material (toluene soluble terphenys and quarterphenyls) for 24 hours under occlusive coverage upon both intact and abraded shaved skin. Subsequently, the excess material was wiped from the treated sites of the animals. Scorings were recorded 24 and 72 hours after topical application. Animals showing signs of irritation after 72 hours were further observed for signs of irritation on the seventh and tenth day after exposure. Only signs of slight erythema were observed.
The target substance Reaction mass of m-terphenyl and o-terphenyl and the source substance terphenyl (containing mainly m-terphenyl, o-terphenyl and p-terphenyl as well as ca. 35 % quarterphenyls) used in this study belong to the group of closely related aromatic hydrocarbons. Also known as diphenylbenzenes or triphenyls, they consist of a central benzene ring substituted with two phenyl groups.
Therefore, both substances are expected to follow the same toxicokinetic pattern. For the detailed procedure of the read-across principle and justifications, please refer to the analogue approach justification depicted above.
Executive summary:

The key study for skin irritation/corrosion is a K1 GLP study performed similar to OECD guideline 404, in which the Draize scoring system is used. New Zealand White rabbits were exposed to 0.5 g of the test material for 24 hours under occlusive coverage upon both intact and abraded shaved skin. Subsequently, the excess material was wiped from the treated sites of the animals. Scorings were recorded 24 and 72 hours after topical application. Animals showing signs of irritation after 72 hours were further observed for signs of irritation on the seventh and tenth day after exposure. Only signs of slight erythema were observed. A primary Irritation Index of 0.1 on a scale of 0.0 to 8.0 was calculated following continous 24 -hour dermal exposure of the intact and abraded skin of six rabbits to the test item. All skin irritation had subsided by the tenth day after read across test material (Toluene soluble terphenyl and quarterphenyls) administration.

The target substance Reaction mass of m-terphenyl and o-terphenyl and the source substance terphenyl (containing mainly m-terphenyl, o-terphenyl and p-terphenyl as well as ca. 35 % quarterphenyls) used in this study belong to the group of closely related aromatic hydrocarbons. Also known as diphenylbenzenes or triphenyls, they consist of a central benzene ring substituted with two phenyl groups.

Therefore, both substances are expected to follow the same toxicokinetic pattern. For the detailed procedure of the read-across principle and justifications, please refer to the analogue approach justification depicted above.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
In this justification, the read-across (bridging) concept is applied, based on the chemical structure of the potential analogues, their toxicokinetic behaviour and other available (eco-)toxicological data.

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The target substance Reaction mass of m-terphenyl and o-terphenyl and the source substance terphenyl (containing mainly m-terphenyl, o-terphenyl and only little p-terphenyl as well as a low percentage of quarterphenyls) used in this study belong to the group of closely related aromatic hydrocarbons. Also known as diphenylbenzenes or triphenyls, they consist of a central benzene ring substituted with two phenyl groups. Obviously, the contained isomers are only different to a minor extent. Moreover, all isomers have common functional group(s). In addition, they were simulated to have the same breakdown products using the In vivo rat metabolism simulator and the Rat liver S9 metabolism simulator (OECD QSAR Toolbox v4.2).
Therefore, both substances are expected to follow the same toxicokinetic pattern.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)

source substance:
Mixture of terphenyls (ca. 60 %; mainly m- and o-terphenyls and only a minor content of p-terphenyl) and quarterphenyls (ca. 35 %)
structural formula: C18H14 and C24H18
The terphenyl substance consists of three constituents, each with their own Smiles notation and structural formula:
o-terphenyl: c(c(c(cccc1)c1)ccc2)(c(cccc3)c3)c2
m-terphenyl: c(c(cccc1)c1)(cccc2c(cccc3)c3)c2
p-terphenyl: c(c(cccc1)c1)(ccc(c(cccc2)c2)c3)c3
The quarterphenyls:
ortho-/ortho-:c1cccc(c1c1ccccc1)c1ccccc1c1ccccc1
ortho-/meta-: c1c(cccc1c1ccccc1c1ccccc1)c1ccccc1
ortho-/para-: c1cc(ccc1c1ccccc1)c1ccccc1c1ccccc1
meta-/meta-: c1c(cccc1c1cccc(c1)c1ccccc1)c1ccccc1
meta-/para-: c1cc(ccc1c1ccccc1)c1cccc(c1)c1ccccc1
para-/para-: c1cc(ccc1c1ccccc1)c1ccc(cc1)c1ccccc1
CAS 26140-60-3
EC No 247-477-3
purity: not specified

target substance:
Reaction mass of m-terphenyl and o-terphenyl (100 % m- and o-terphenyl)
structural formula: C18H14
The substance consists of two constituents, each with their own Smiles notation and structural formula:
o-terphenyl: c(c(c(cccc1)c1)ccc2)(c(cccc3)c3)c2
m-terphenyl: c(c(cccc1)c1)(cccc2c(cccc3)c3)c2
CAS -
EC No 904-797-4
purity: ≥ 90 - ≤ 100 % (w/w)

3. ANALOGUE APPROACH JUSTIFICATION
Reaction mass of m-terphenyl and o-terphenyl and Mixture of terphenyls (ca. 60 %) and quarterphenyls (ca. 35 %) belong to the group of closely related aromatic hydrocarbons. Terphenyls, also known as diphenylbenzenes or triphenyls, consist of a central benzene ring substituted with two phenyl groups.

Both chemicals are expected to be metabolised similarly building similar metabolites (“common breakdown product").
The similar findings (refer to data matrix outlined below) for both substances support the conclusion that similar molecules will be formed from both substances when applied systemically. In consequence, Mixture of terphenyls and quarterphenyls may perfectly serve as read-across substance for Reaction mass of m-terphenyl and o-terphenyl and vice versa. So, the available data on Mixture of terphenyls and quarterphenyls can be used to cover all systemic endpoints currently lacking from Reaction mass of m-terphenyl and o-terphenyl, making further testing obsolete.

4. DATA MATRIX
There is mainly physico-chemical data available on the toxicological properties of Reaction mass of m-terphenyl and o-terphenyl. Data on Mixture of terphenyls and quarterphenyls covers among others the toxicokinetic, acute toxicity, irritation / corrosion and genetic mutation in vitro endpoint. The identification and discussion of common properties will be based on available data including toxicological and physicochemical data.
The physical state of the two substances is solid (Reaction Mass of m-terphenyl and o-terphenyl is a cream coloured solid block at room temperature; Mixture of terphenyls and quarterphenyl is a soft solid at room temperature, melting to a yellow liquid). Their melting point lies at 32 °C and 145 °C; their boiling point at 355°C and 343°C. Furthermore, their density is quite similar (1.11 x 10E3 kg/m3 at 20.0 ± 0.5 ºC and 1.133 x 10E3 kg/m3 at 25 ºC) and the vapour pressure is also in the same range (1.8 x 10E-2 Pa at 25 °C (corresponding to 1.7765 x 10E-7 atmosphere) and 1.6x10-5to 3.0x10E-14 atmosphere; the estimated vapour pressure of the o-, m- and p-terphenyls ranged from 4.3 x 10E-7 to 8.0 x 10E-10 atmosphere).
The available data for the following physico-chemical properties, which are relevant for absorption into living organisms, are very similar. Both substances are medium sized molecules with a molecular weight of 230.31 (Reaction mass of m-terphenyl and o-terphenyl) resp. 230 and 306 (terphenyls and quarterphenyls)), they are both insoluble and slightly soluble in water (Less than 1.0 x 10E-4 g/L of solution at 20.0 ± 0.5 °C (Reaction mass of m-terphenyl and o-terphenyl) and 0.151 mg/L at 25°C (Mixture of terphenyls and quarterphenyls), respectively). Moreover, they have a rather high logPow (3.01 to 5.94 (Reaction mass of m-terphenyl and o-terphenyl) and 5.86 at 22°C (Mixture of terphenyls and quarterphenyls)). Both chemicals are not readily biodegradable and they are not expected to be hydrolysed due to lack of functional groups. For Reaction mass of m-terphenyl and o-terphenyl a QSAR calculation has been performed for the bioconcentration factor (BCF). For both - m-terphenyl and o-terphenyl - a BCF of 2041 L/kg wet-wt (3.31 log BCF) was predicted. Mixture of terphenyls and quarterphenyls has a low potential for bioaccumulation in aquatic organisms.

There is only data available for the target substance Reaction mass of m-terphenyl and o-terphenyl for the following toxicological endpoints: Repeated dose toxicity oral and Toxicity to reproduction (fertility / developmental toxicity).
Moreover, there is data available for the Read Across substance Mixture of terphenyls and quarterphenyls for the following endpoints: Acute toxicity oral, Acute toxicity dermal, Skin irritation / corrosion, Eye irritation /corrosion, Genetic toxicity in vitro.
The Read Across substance Mixture or terphenyls and quarterphenyls has been shown to be not acutely toxic and not irritating to the skin or the eyes. In addition, the Read Across substance has been shown to be not mutagenic. For Reaction mass of m-terphenyl and o-terphenyl a NOAEL of 100 mg/kg bw was derived for the endpoint Repeated dose toxicity oral and for reproduction / developmental toxicity, based on effects around parturition at 300 mg/kg/day.
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.6
Max. score:
110
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.06
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
< 0.2
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
< 0.2
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks:
.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: not specified
Remarks:
.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: not specified
Remarks:
.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: not specified
Remarks:
.
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Remarks on result:
other: not specified
Remarks:
.
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Remarks on result:
other: not specified
Remarks:
.
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Remarks on result:
other: not specified
Remarks:
.

The individual and the 24, 48, and 72 hour average Draize scores for the six rabbit eyes treated with the toluene soluble terphenyl and quarterphenyl test item are summarized below.

The average Draize score for this roup of animals is 0.6 on a scale of 0 to 110. All irritation had subsided by the second day after exposure.

Primary Eye Irritation to Rabbits Individual Irritation Scores

Animal n°

Obs. day

Cornea

Iris

Conjunctivae

Total

Average of 24, 48, 72 h

01M01

1

5

0

0

5

1.7

2

0

0

0

0

3

0

0

0

0

01M02

1

0

0

0

0

0.0

2

0

0

0

0

3

0

0

0

0

01M03

1

0

0

2

2

0.7

2

0

0

0

0

3

0

0

0

0

01F02

1

0

0

4

4

1.3

2

0

0

0

0

3

0

0

0

0

01F02

1

0

0

0

0

0.0

2

0

0

0

0

3

0

0

0

0

01F03

1

0

0

0

0

0.0

2

0

0

0

0

3

0

0

0

0

Interpretation of results:
not irritating
Conclusions:
This key study for eye irritation is performed according to GLP and similar to OECD guideline 405, in which the Draize scoring system is used. New Zealand White rabbits were exposed to a single dose of 76 mg of the toluene soluble terphenyl and quarterphenyl test substance via the eye. Signs of irritation were recorded on the first, second and third day after dosing. Only on the first day signs of irritation were noted in 3 of the 6 test animals. By day 2, all animals were free of irritation signs.
The target substance Reaction mass of m-terphenyl and o-terphenyl and the source substance terphenyl (containing mainly m-terphenyl, o-terphenyl and p-terphenyl as well as ca. 35 % quarterphenyls) used in this study belong to the group of closely related aromatic hydrocarbons. Also known as diphenylbenzenes or triphenyls, they consist of a central benzene ring substituted with two phenyl groups.
Therefore, both substances are expected to follow the same toxicokinetic pattern. For the detailed procedure of the read-across principle and justifications, please refer to the analogue approach justification depicted above.
Executive summary:

When 76 mg (the 0.1 mL equivalent) of the test item (Toluene soluble terphenyl and quarterphenyls) was instilled into the conjunctival sac of the albino rabbit eye, the average of the Draize scores for 24, 48, and 72 hours was 0.6 on a scale of 0 to 110 for six eyes. All irritation had susided by the second day after exposure.

The target substance Reaction mass of m-terphenyl and o-terphenyl and the source substance terphenyl (containing mainly m-terphenyl, o-terphenyl and p-terphenyl as well as ca. 35 % quarterphenyls) used in this study belong to the group of closely related aromatic hydrocarbons. Also known as diphenylbenzenes or triphenyls, they consist of a central benzene ring substituted with two phenyl groups.

Therefore, both substances are expected to follow the same toxicokinetic pattern. For the detailed procedure of the read-across principle and justifications, please refer to the analogue approach justification depicted above.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are no data available for the target substance. However, several reliable test results are available for structurally related read across substances. The results of these will be described in the following.

Skin irritation/corrosion:

The key study for skin irritation/corrosion with a structurally related analogous Mixture of terphenyls and quarterphenyls is a K1, GLP study performed similar to OECD guideline 404, in which the Draize scoring system is used. New Zealand White rabbits were exposed to 0.5 g of Mixture of terphenyls and quarterphenyls for 24 hours under occlusive coverage upon both intact and abraded shaved skin. Subsequently, the excess material was wiped from the treated sites of the animals. Scorings were recorded 24 and 72 hours after topical application. Animals showing signs of irritation after 72 hours were further observed for signs of irritation on the seventh and tenth day after exposure. Only signs of slight erythema were observed.

Several supporting studies are available as well with structurally related read across substances. A K2 study on a Mixture of terphenyls also indicates that the substance is not an irritant. There is another K3 study present in the current IUCLID file, which can not be used for classification purposes. The study (Haley et al. 1959) describes the effects of different polyphenyl mixtures and of the individual terphenyl isomers. The two described mixtures are clearly not comparable to the current mixtures which are being produced and therefore not relevant for this assessment. The results on the isomers are relevant and indicate that the isomers are not irritating.

Eye irritation:

The K1 key study for eye irritation with a structurally related analogous Mixture of terphenyls and quarterphenyls is performed according to GLP and similar to OECD guideline 405, in which the Draize scoring system is used. New Zealand White rabbits were exposed to a single dose of 76 mg of a Mixture of terphenyls and quarterphenyls via the eye. Signs of irritation were recorded on the first, second and third day after dosing. Only on the first day signs of irritation were noted in 3 of the 6 test animals. By day 2, all animals were free of irritation signs.

Furthermore, some supporting studies are available with structurally related read across substances. A study on a Mixture of terphenyls (K2), suggested mild irritation, but the effects appeared to be fully reversible resulting in categorization of the chemical as not irritating. There was one additional study available describing the effects of a polyphenyl mixture (Haley et al. 1959), however the composition of the mixture is clearly different from the currently produced mixtures and therefore these results are not taken into account.

 

Justification for classification or non-classification

Based on the available data on the read across substances data, the target substance reaction mass of m-terphenyl and o-terphenyl does not meet the criteria under Regulation (EC) No 1272/2008 for classification and labelling as a skin irritant or eye irritant.