Iso(C10-C14)alkyl (3,5-di-tert-butyl-4-hydroxyphenyl)methylthioacetate

Endpoint summary

Description of key information

The test substance is not irritating or corrosive to the rabbit skin. The test substance is not irritating to the rabbits eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-03-01 to 1988-03-21

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study, GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Füllinsdorf
- Age at study initiation: Approx. 12-14 weeks
- Weight at study initiation: 2110 to 2610g
- Housing: Individually in metal cages
- Diet: Standard rabbit pellet, Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/-3°C
- Humidity: 30-70%
- Photoperiod: 12 hrs light cycle

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: the contralateral flank of each rabbit served as control (control gauze patch)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL of the test item

Duration of treatment / exposure:

4 hrs

Observation period:

7 days

Number of animals:

3 female rabbits

Details on study design:

TEST SITE
- Area of exposure: approx. 36 cm2 on flanks of the animals
- Type of wrap: the patches were loosely covered with an aluminum foil (approx. 36 cm2) and held in place by an adhesive tape (Isoplast)

SCORING SYSTEM: OECD scoring system

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48, 72 hrs

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Irritant / corrosive response data:

Minimal erythema was observed in one animal, reversible within 24 hours. The same animal also showed minimal signs of edema, reversible within 72 hours. The other two animals did not show any signs of irritation.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item was not irritant to the rabbit skin under the conditions of this study.

Executive summary:

An acute skin irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of the test substance (described in section 1.2) on the albino rat skin. This test was based on the OECD Guideline No. 404 (Acute Dermal Irritation/ Corrosion) and was performed on 3 female rabbits, checked for normal skin conditions. A gauze patch bearing 0.5 mL of the test article was applied to the flank of each animal and held in place for 4 hours by an adhesive tape. A control gauze patch was applied to the contralateral flank. Because slight reactions were observed within 72 hours after dermal application of the test article, the observation period was extended to 7 days to determine the reversibility of the skin reactions. Only minimal erythema was observed in one animal, reversible within 24 hours. The same animal also showed a minimal edema, reversible within 72 hours. The other two animals did not show any signs of irritation. Based on the study results, the test item was found to be not irritating to the rabbit skin.

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:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study, GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Füllinsdorf
- Age at study initiation: Approx. 12-14 weeks
- Weight at study initiation: 2330 to 2430g
- Housing: Individually in metal cages
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/-3°C
- Humidity: 30-70%
- Photoperiod: 12 hrs light cycle

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye remained untreated and served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1mL of the test substance

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

1, 24, 48, 72 hrs

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

SCORING SYSTEM: OECD scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hrs

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Irritant / corrosive response data:

Mild conjunctival redness and chemosis were observed in all three animals. These effects reverted back to normal within 48 hours. No other signs of irritation were reported.

Other effects:

A slight loss of weight was observed in animal on day 3 (considered not to be treatment - related).

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item was not irritating to the rabbit eye under the conditions of this study.

Executive summary:

An acute eye irritation/corrosion study in New Zealand white rabbits was performed to determine the irritant or corrosive potency of the test item (described in section 1.2). The test was based on the OECD Guideline No. 405 (Acute Eye Irritation/ Corrosion) and was performed on 3 male rabbits, checked for normal eye conditions. 0.1 mL of the test item was placed into the conjunctival sac of the left eye of each animal. The lids were then held together for about one second in order to prevent loss of the test article. The animals were checked daily for systemic symptoms and mortality. A slit-lamp was used to facilitate the evaluation. The mean values of the Draize scores at 24, 48 and 72 hrs after application were 1/0/0 for redness and 0/0/0 for chemosis of the conjunctiva. No effects were seen on the opacity of the cornea and on the iris. The test item was no eye irritant under the conditions of this study.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation:

A GLP-compliant acute skin irritation/corrosion study in albino rabbits was performed to determine the irritant or corrosive potency of the test substance on the albino rabbit skin. This test was based on OECD Guideline No. 404 (Acute Dermal Irritation/ Corrosion) and was performed on 3 female rabbits, checked for normal skin conditions. A gauze patch bearing 0.5 mL of the test article was applied to the flank of each animal and held in place for 4 hours by an adhesive tape. A control gauze patch was applied to the contralateral flank. Minimal erythema reaction (average score of 0.7) was observed in one animal, reversible within 24 hours. The same animal also showed minimal erythema reactions, reversible within 72 hours. The other two animals did not show any signs of irritation (Ciba-Geigy, 1988).

In a second skin irritation study following OECD guideline 401 and compliant with GLP, three New Zealand White rabbits were treated with 0.5 ml of the test substance for 4 hours under semiocclusive conditions and skin reactions were observed for 7 days. Mild erythema and edema were noted in all animals from 1 hour after removal of the gauze patch. All effects were reversible within 7 days in 2 animals. The average scores (24, 48 and 72h) in these animals were 1.3 for erythema and 1.0 for edema. One animal still showed signs of erythema and edema at study termination after 7 days. This effect is expected to have reversed back to normal skin conditions if the observation period would have been extended. The average scores (24, 48 and 72h) were 1.3 for both erythema and edema in this animal. Based on these results, the test item is considered to be not irritating to the rabbit skin (Ciba-Geigy, 1983).

Eye irritation:

A GLP-compliant acute eye irritation/corrosion study in New Zealand white rabbits was performed to determine the irritant or corrosive potency of the test item. The test was based on the OECD Guideline No. 405 (Acute Eye Irritation/ Corrosion) and was performed on 3 male rabbits, checked for normal eye conditions. 0.1 mL of the test item was placed into the conjunctival sac of the left eye of each animal. The lids were then held together for about one second in order to prevent loss of the test item. The mean values of the Draize scores at 24, 48 and 72 hrs after application were 1/0/0 for redness and 0/0/0 for chemosis of the conjunctiva. No effects were seen on the opacity of the cornea and on the iris. Based on this result, the test item was classified as not irritant (Ciba-Geigy, 1988).

This was confirmed in a second GLP compliant eye irritation study following OECD guideline 405, where the test article was instilled into the conjunctival sac of three rabbits and the ocular reactions were recorded for 7 days. Mild conjunctival redness and chemosis was observed in all animals from one hour after treatment, reversible within 7 days the latest. Average scores (24, 48 and 72 hours) were 0.56 for both redness and chemosis. Additionally, one animal showed minimal reactions to the cornea and iris one hour after the instillation; these effects were reversible within 24 hours and did not result in any 24-72h scores. Based on these results, the test item is considered to be not irritating to the rabbit eye (Ciba-Geigy, 1983).

Justification for selection of skin irritation / corrosion endpoint:
GLP-compliant guideline study

Justification for selection of eye irritation endpoint:
GLP-compliant guideline study

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. 

Based on the data, the test substance has not to be classified as skin or eye irritant.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008.

Based on the data, the test substance has not to be classified as skin or eye irritant.