Stoddard solvent

Endpoint summary

Description of key information

Skin irritation

The test substance is irritating to skin according to the DSD and CLP.

The exposure caused moderate to severe erythema and oedema according to the Draize test after 24 h of skin contact. After 72 h, a primary dermal irritation index of 4.5 was calculated

 

Eye irritation

Stoddard solvent was administered to one eye of six New Zealand White rabbits to assess for ocular irritation. Observations were made at 24, 48 and 72 hours and 7 days after treatment. Ocular damage was assessed and scored according to the Draize eye test. Ocular irritation was most prominent at the 48 and 72 hour observation period receiving a Draize score of 0.22. Irritation subsided and all animals were clear of ocular irritation within 7 days after treatment. The mean corneal opacity, iris lesion and conjunctivae redness, scores were 0.05, 0.05 and 0.22, respectively. These findings do not warrant classification of Stoddard solvent as an ocular irritant under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations Result: not irritating at 0.1 mL.

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:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

Stoddard solvent (14.5% aromatics) CAS (8052-41-3) Boiling Point Range 160-199 °C

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.6-3.5 kg
- Housing: individual cages, identified with ear tags
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiat ad libitum, 15 g/day
- Water (e.g. ad libitum): deionized water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degree C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12 hrs

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

24 hrs

Observation period:

Observations were made at 24 and 72 hrs after end of exposure.

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: dorsal trunk area
- % coverage: 2.5 x 2.5 cm area
- Type of wrap if used: cellulose bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): removed with lukewarm water
- Time after start of exposure: 4 hrs

SCORING SYSTEM: Draize scale

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

72 h

Score:

4.5

Reversibility:

not specified

Remarks on result:

other: moderate to severe irritant; edema after 24 hrs

Irritant / corrosive response data:

The exposure caused moderate to severe erythema and oedema according to the Draize test after 24 h of skin contact. After 72 h, a primary dermal irritation index of 4.5 was calculated

Other effects:

Microscopic examination showed hardening of the skin, hyperkeratosis, and misalignment with nearby skin.

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test substance is irritating to skin according to the DSD and CLP.
The exposure caused moderate to severe erythema and oedema according to the Draize test after 24 h of skin contact. After 72 h, a primary dermal irritation index of 4.5 was calculated

Executive summary:

In a test for primary dermal irritation, 0.5 ml of Stoddard solvent (14.5% aromatics) was applied to the shaved (abraded and nonabraded) skin of six male New Zealand White rabbits. The exposed area was covered with an occlusive dressing for 24 h. The exposure caused moderate to severe erythema and oedema according to the Draize test after 24 h of skin contact. After 72 h, a primary dermal irritation index of 4.5 was calculated

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Application of 200, 1000 and 2000 mg/kg of white spirit (Stoddard solvent) to the shaved intact skin (15 × 20 cm2) of 10 New Zealand White rabbits 3 times a week for 4 weeks

GLP compliance:

yes

Specific details on test material used for the study:

Stoddard solvent (14.5% aromatics) CAS (8052-41-3) Boiling Point Range 160-199 °C

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.6-3.5 kg
- Housing: individual cages, identified with ear tags
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiat ad libitum, 15 g/day
- Water (e.g. ad libitum): deionized water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degree C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12 hrs

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Application of 200, 1000 and 2000 mg/kg of white spirit (Stoddard solvent) to the shaved intact skin (15 × 20 cm2) of 10 New Zealand White rabbits 3 times a week for 4 weeks

Duration of treatment / exposure:

28 days

Observation period:

28 days

Number of animals:

10

Details on study design:

Application of 200, 1000 and 2000 mg/kg of white spirit (Stoddard solvent) to the shaved intact skin (15 × 20 cm2) of 10 New Zealand White rabbits 3 times a week for 4 weeks resulted in a dose-related increase in irritation response (Draize testing). Following the application, the test site was occluded for 6 h with a gauze pad and a sheet of polyethylene.

SCORING SYSTEM: Draize scale

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 28 d

Score:

4.5

Reversibility:

not specified

Remarks on result:

other: "Moderate irritation" was observed at the lowest dose level and "severe irritation" at the highest dose level

Irritant / corrosive response data:

The exposure caused moderate to severe erythema and oedema according to the Draize test after 3 times a week for 4 weeks of skin contact.

Other effects:

Microscopic examination showed hardening of the skin, hyperkeratosis, and misalignment with nearby skin.

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test substance is irritating to skin according to the DSD and CLP.
The exposure caused moderate to severe erythema and oedema according to the Draize test after 3 times a week for 4 weeks of skin contact.

Executive summary:

Application of 200, 1000 and 2000 mg/kg of white spirit (Stoddard solvent) to the shaved intact skin (15 × 20 cm2) of 10 New Zealand White rabbits 3 times a week for 4 weeks resulted in a dose-related increase in irritation response (Draize testing). Following the application, the test site was occluded for 6 h with a gauze pad and a sheet of polyethylene. "Moderate irritation" was observed at the lowest dose level and "severe irritation" at the highest dose level

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Specific details on test material used for the study:

Stoddard solvent CAS (8052-41-3)

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

24 hrs

Observation period:

Observations were made at 24 hrs after end of exposure.

Number of animals:

6

Details on study design:

The application site was covered with gauze and an elastic bandage for a duration of 24 h.

SCORING SYSTEM: Draize scale

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24 h

Score:

1.55

Reversibility:

not specified

Remarks on result:

other: minor signs of irritation after 24 hrs

Irritant / corrosive response data:

The exposure caused minor signs of irritation according to the Draize test after 24 h of skin contact. After 24 h, a primary dermal irritation index of 1.55 was calculated

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

The test substance is mild irritant to skin according to the GHS criteria.
In a skin irritation test with New Zealand White rabbits exposed to white spirit (Stoddard solvent), was only minor signs of irritation and hence calculated an index of 1.55.

Executive summary:

In a skin irritation test with New Zealand White rabbits exposed to white spirit (Stoddard solvent), was only minor signs of irritation and hence calculated an index of 1.55. The application site was covered with gauze and an elastic bandage for a duration of 24 h.

Reference 4

Endpoint:

skin irritation / corrosion, other

Remarks:

Test substance was applied to 2 different sites for 4 hrs and residual material was removed from site using water vs. white oil.

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

C9-C12 Mixed aliphatic and aromatics (8052-41-3) Boiling Point Range 158-204 °C

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sittingbourne Research Centre breeding colony
- Age at study initiation: 3 to 6 months
- Weight at study initiation: 3.4 kg to 4.9 kg
- Housing: Individual- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 19 °C
- Humidity (%): monitored- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL undiluted applied to 2 different sites for 4 hrs;

Duration of treatment / exposure:

4 hrs

Observation period:

Observations were made at 24,48 and 72 hrs after end of exposure.

Number of animals:

6

Details on study design:

TEST SITE
-0.5 mL undiluted applied to 2 different sites for 4 hrs;
semi-occlusive patch;
residual material removed from site using water vs. white oil
SCORING SYSTEM: Scale of 0 to 4 for both erythema and edema

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.94

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: Mean 24, 48, 72 hr scores (water-wiped site) Erythema 1.94

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.56

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Mean 24, 48, 72 hr scores (water-wiped site) Edema 0.56;

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2.05

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Mean 24, 48, 72 hr scores (oil-wiped site) Erythema 2.05;

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.67

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Mean 24, 48, 72 hr scores (oil-wiped site) Edema 0.67

Irritant / corrosive response data:

The group mean 24, 48, and 72 hour scores (water-wiped site) for erythema and edema were 1.94 and 0.56 respectively.
The group mean 24, 48, and 72 hour scores (oil-wiped site) for erythema and edema were 2.05 and 0.67 respectively.
Under the conditions of this study, the test material was classified as not irritating according to EU criteria.

Interpretation of results:

other: not irritating

Conclusions:

The group mean 24, 48, and 72 hour scores (water-wiped site) for erythema and edema were 1.94 and 0.56 respectively.
The group mean 24, 48, and 72 hour scores (oil-wiped site) for erythema and edema were 2.05 and 0.67 respectively.
Under the conditions of this study, the test material was classified as not irritating according to EU criteria.

Executive summary:

In a skin irritation study, three male and three female rabbits were treated with 0.5 mL of undiluted test material. The test material was applied to 2 different sites for 4 hrs and residual material was removed from site using water vs. white oil. The group mean 24, 48, and 72 hour scores (water-wiped site) for erythema and edema were 1.94 and 0.56 respectively. The group mean 24, 48, and 72 hour scores (oil-wiped site) for erythema and edema were 2.05 and 0.67 respectively. Under the conditions of this study, the test material was classified as not irritating according to EU criteria.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

C9-C12 Mixed aliphatics and aromatics (8052-41-3) Boiling Point (C) 160-199
(Stoddard solvent; 14.5% aromatics)

Species:

rabbit

Strain:

New Zealand White

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): 100%

Duration of treatment / exposure:

24 hrs

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: Non-irritant

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: Non-irritant

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: Non-irritant

Irritant / corrosive response data:

No or only very slight irritation occurred after the application of 0.1 ml of Stoddard solvent to the eyes of six rabbits. One hour after application one of the rabbits showed mild injection and swelling of the conjunctiva. However, these signs of irritative response disappeared after 24 h

Interpretation of results:

other: not irritating

Conclusions:

The eyes of six rabbits were treated with the test substance and observed for 7 days. Results indicate that the substance was not irritating .
One hour after application one of the rabbits showed mild injection and swelling of the conjunctiva. However, these signs of irritative response disappeared after 24 h
Result: not irritating at 0.1 mL.

Executive summary:

No or only very slight irritation occurred after the application of 0.1 ml of Stoddard solvent to the eyes of six rabbits. One hour after application one of the rabbits showed mild injection and swelling of the conjunctiva. However, these signs of irritative response disappeared after 24 h

Reference 2

Endpoint:

eye irritation, other

Remarks:

The test substance was applied into the one eye and a saline solution was applied into the other eye as a control.

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

C8-C13 Mixed aliphatics and aromatics (8052-41-3) Boiling Point (C) 154-189

Species:

rabbit

Strain:

New Zealand White

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): 100%

Duration of treatment / exposure:

24 hrs

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: Non-irritant

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.05

Reversibility:

fully reversible within: 24 h

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.05

Reversibility:

fully reversible within: 24 h

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Stoddard solvent was administered to one eye of six New Zealand White rabbits to assess for ocular irritation. Observations were made at 24, 48 and 72 hours and 7 days after treatment. Ocular damage was assessed and scored according to the Draize eye test. Ocular irritation was most prominent at the 48 and 72 hour observation period receiving a Draize score of 0.22. Irritation subsided and all animals were clear of ocular irritation within 7 days after treatment. The mean corneal opacity, iris lesion and conjunctivae redness, scores were 0.05, 0.05 and 0.22, respectively. These findings do not warrant classification of Stoddard solvent as an ocular irritant under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations

Interpretation of results:

other: not irritating

Conclusions:

Stoddard solvent was administered to one eye of six New Zealand White rabbits to assess for ocular irritation. Observations were made at 24, 48 and 72 hours and 7 days after treatment. Ocular damage was assessed and scored according to the Draize eye test. Ocular irritation was most prominent at the 48 and 72 hour observation period receiving a Draize score of 0.22. Irritation subsided and all animals were clear of ocular irritation within 7 days after treatment. The mean corneal opacity, iris lesion and conjunctivae redness, scores were 0.05, 0.05 and 0.22, respectively. These findings do not warrant classification of Stoddard solvent as an ocular irritant under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations
Result: not irritating at 0.1 mL.

Executive summary:

Stoddard solvent was administered to one eye of six New Zealand White rabbits to assess for ocular irritation. Observations were made at 24, 48 and 72 hours and 7 days after treatment. Ocular damage was assessed and scored according to the Draize eye test. Ocular irritation was most prominent at the 48 and 72 hour observation period receiving a Draize score of 0.22. Irritation subsided and all animals were clear of ocular irritation within 7 days after treatment. The mean corneal opacity, iris lesion and conjunctivae redness, scores were 0.05, 0.05 and 0.22, respectively. These findings do not warrant classification of Stoddard solvent as an ocular irritant under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations

Result: not irritating at 0.1 mL.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation

The test substance is irritating to skin according to the DSD and CLP.

The exposure caused moderate to severe erythema and oedema according to the Draize test after 24 h of skin contact. After 72 h, a primary dermal irritation index of 4.5 was calculated

 

Eye irritation

Stoddard solvent was administered to one eye of six New Zealand White rabbits to assess for ocular irritation. Observations were made at 24, 48 and 72 hours and 7 days after treatment. Ocular damage was assessed and scored according to the Draize eye test. Ocular irritation was most prominent at the 48 and 72 hour observation period receiving a Draize score of 0.22. Irritation subsided and all animals were clear of ocular irritation within 7 days after treatment. The mean corneal opacity, iris lesion and conjunctivae redness, scores were 0.05, 0.05 and 0.22, respectively. These findings do not warrant classification of Stoddard solvent as an ocular irritant under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations Result: not irritating at 0.1 mL.

Justification for classification or non-classification

Based on the hazard assessment of Stoddard solvent, in section 2.1 and 2.2. in IUCLID 6., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health”, according to the EU’s list of dangerous substances (OJEC No L200/130.7.99) and according to the criteria described in Directive 67/548 and in the CLP Regulation:

 

Directive 67/548

Skin Corrosivity C R35 Causes severe burns R34 Causes burns Skin Irritation Xi R38 Irritating to skin R43 May cause sensitization by skin contact Eye Irritation (Ocular Lesions) Xi R36 Irritating to eyes R37 irritating to respiratory system R41 Risk of serious damage to eyes

CLP

Skin Corrosivity H314 Skin Corr 1A Causes severe skin burns and eye damage H314 Skin Corr 1B Causes severe skin burns and eye damage Skin Irritation H315 Skin Irrit. 2 Causes skin irritation H317 Skin Sens. 1 May cause an allergic skin reaction Eye Irritation (Ocular Lesions) Xi H319 Eye Irrit. 2 Causes serious eye irritation H318 Eye Dam. 1 Causes serious eye damage H335 STOT SE 3 May cause respiratory irritation

 

  

It is concluded that the substance Stoddard solvent meet the criteria to be classified for human health hazards for Skin Irritation and does not meet for Eye Irritation and does not meet for respiratory irritation:

R38 Irritating to skin

H315 Skin Irrit. 2 Causes skin irritation,