Octanoic acid, mixed tetraesters with 2-ethylhexanoic acid, heptanoic acid and pentaerythritol

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From June 1994 to August 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

read-across

Justification for type of information:

Refer to the section 13 for details on the read across justification. The skin irritation study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

limited documentation but relevant data given

GLP compliance:

yes

Species:

rabbit

Strain:

not specified

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

yes

Duration of treatment / exposure:

4 h

Observation period:

Time points: 30 - 60 min, 24, 48 and 72 h

Number of animals:

3 females

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The only sign of irritation was a slight transient erythema observed in all three rabbits 30-60 min after patch removal.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the substance was non-irritating to rabbit skin.

Executive summary:

A study was conducted to determine the skin irritation potential of the read-across substance CAS 7299 -99 -2 in rabbits according to a method similar to OECD Guideline 404. The test substance was applied to the shaved skin of 3 female rabbits under a semi-occlusive patch for 4 h. Upon patch removal, the exposed skin was observed for signs of skin irritation at 30 -60 min, 24, 48 and 72 h. The only sign of irritation was a slight transient erythema observed in all three rabbits 30 -60 min after patch removal. Under the study conditions, the test substance was non-irritating to rabbit skin (Zeneca, 1994).

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

From June 1994 to August 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Read-across

Justification for type of information:

The supporting skin irritation study is considered sufficient to fulfil the information requirement.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 4924 - 5154 g
- Sex: Female

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL of the test sample

Duration of treatment / exposure:

4 hours

Observation period:

Observation time points: 30 - 60 min, 24, 48, 72 and 96 h

Number of animals:

Three females

Details on study design:

The test sample was applied to a 2.5 cm square area on the shaved left flank of the dorso-lumbar area.

REMOVAL OF TEST SUBSTANCE
- Washing: cleansing with clean warm water
- Time after start of exposure: 4 h (upon removal of the dressing)

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1.3

Max. score:

4

Reversibility:

fully reversible within: 4 d

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 1.7

Max. score:

4

Reversibility:

fully reversible within: 4 d

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 1.3

Max. score:

4

Reversibility:

fully reversible within: 4 d

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the substance was not considered to be irritating to rabbit skin.

Executive summary:

A study was conducted to determine the skin irritation potential of the read-across substance CAS 68424 -31 -7 according to a method similar to OECD Guideline 404. Three female New Zealand White albino rabbits were used in the study. Approximately 0.5 mL of the test substance was applied to a 2.5 cm square area on the shaved left flank of the dorso-lumbar region of each animal under a semi-occlusive dressing for 4 h. Upon removal of the dressing, the skin was cleansed with clean warm water. The application sites were assessed for signs of erythema and oedema and scored according to the Draize scale at approximately 30 -60 min, 24, 48, 72 and 96 h after removal of the dressings. Very slight to well-defined erythema and very slight oedema were observed up to 72 h after application and the signs were resolved 96 h after application. Under the study conditions, the substance was not considered to be irritating to rabbit skin (Robinson, 1991).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

RA study

Justification for type of information:

Refer to the section 13 of IUCLID dataset for details on the read across justification. The eye irritation study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not required

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

3 animals

Details on study design:

SCORING SYSTEM: Draize

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

All signs of irritation had completely regerssed three days after instillation

Key scores for labelling

Lesion	16	17	18
Corneal opacity	0	0	0
Iritis	0	0	0
Conj redness	0.33	0.67	0.67
Chemosis	0.33	0	0

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the substance was not considered to be irritating to the rabbit eye.

Executive summary:

A study was conducted to determine the eye irritation potential of the read-across substance CAS 7299 -99 -2 according to a method similar to OECD Guideline 405. Three New Zealand White rabbits were used in the study. After instillation of the test substance into eyes of rabbits, the irritation effects were observed at 24, 48 and 72 h. Scoring of the irritation reactions was performed according to the Draize scale. Apart from conjunctival redness in all three animals (which resolved within 72 h) and chemosis in one animal (which resolved within 48 h), no other sign of irritation could be observed. Under the study conditions, the substance was not considered to be irritating to the rabbit eye (Duerden, 1994).

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

RA study

Justification for type of information:

The supporting eye irritation study is considered sufficient to fulfil the information requirement.

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3556-4556 g

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): pure- single application without washing

Duration of treatment / exposure:

No Data

Observation period (in vivo):

3 d

Number of animals or in vitro replicates:

3 females

Details on study design:

SCORING SYSTEM: Draize scoring system

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No corneal or iridial effects were observed. Conjunctival effects included slight redness (1 animal) and slight discharge (1 animal) and were transiently seen approximately 1 h after dosing.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the substance was not considered to be irritating to rabbit eyes.

Executive summary:

A study was conducted to determine the eye irritation potential of the read-across substance CAS 68424 -31 -7 according to a method similar to OECD Guideline 405. Three female New Zealand White rabbits were used in the study. 0.1 mL of the test substance was instilled into the conjunctival sac of the left eye of each rabbit. During an observation period of up to three days, the ocular reactions to the test substance were scored according to Draize scale. No treatment-related corneal or iridial effects were observed. Conjunctival effects included slight redness (one animal) and slight discharge (one animal) seen approximately one hour after dosing. No other signs of irritation were observed. Under the study conditions, the substance was not considered to be irritating to rabbit eye (Robinson, 1991).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

A study was conducted to determine the skin irritation potential of the read-across substance CAS 7299 -99 -2 in rabbits according to a method similar to OECD Guideline 404. The test substance was applied to the shaved skin of 3 female rabbits under a semi-occlusive patch for 4 h. Upon patch removal, the exposed skin was observed for signs of skin irritation at 30-60 min, 24, 48 and 72 h. The only sign of irritation was a slight transient erythema observed in all three rabbits 30-60 min after patch removal. Under the study conditions, the substance was non-irritating to rabbit skin (Duerden, 1994).

A supporting study was conducted to determine the skin irritation potential of the read-across substance CAS 68424 -31 -7 according to a method similar to OECD Guideline 404. Three female New Zealand White albino rabbits were used in the study. Approximately 0.5 mL of the test substance was applied to a 2.5 cm square area on the shaved left flank of the dorso-lumbar region of each animal under a semi-occlusive dressing for 4 h. Upon removal of the dressing, the skin was cleansed with clean warm water. The application sites were assessed for signs of erythema and oedema and scored according to the Draize scale at approximately 30 -60 min, 24, 48, 72 and 96 h after removal of the dressings. Very slight to well-defined erythema and very slight oedema were observed up to 72 h after application and the signs were resolved 96 h after application. Under the study conditions, the substance was not considered to be irritating to rabbit skin (Robinson, 1991).

Eye irritation:

A study was conducted to determine the eye irritation potential of the read-across substance CAS 7299 -99 -2 according to a method similar to OECD Guideline 405. Three New Zealand White rabbits were used in the study. After instillation of the test substance into eyes of rabbits, the irritation effects were observed at 24, 48 and 72 h. Scoring of the irritation reactions was performed according to the Draize scale. Apart from conjunctival redness in all three animals (which resolved within 72 h) and chemosis in one animal (which resolved within 48 h), no other sign of irritation could be observed. Under the study conditions, the substance was not considered to be irritating to the rabbit eye (Duerden, 1994).

A supporting study was conducted to determine the eye irritation potential of the read-across substance CAS 68424 -31 -7 according to a method similar to OECD Guideline 405. Three female New Zealand White rabbits were used in the study. 0.1 mL of the test substance was instilled into the conjunctival sac of the left eye of each rabbit. During an observation period of up to three days, the ocular reactions to the test substance were scored according to Draize scale. No treatment-related corneal or iridial effects were observed. Conjunctival effects included slight redness (one animal) and slight discharge (one animal) seen approximately one hour after dosing. No other signs of irritation were observed. Under the study conditions, the substance was not considered to be irritating to rabbit eye (Robinson, 1991).

Justification for classification or non-classification

Based on the in vivo skin and eye irritation studies in rabbits with the read-across substances, the substance does not warrant any classification according to the EU CLP (EC 1272/2008) criteria.