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EC number: 232-092-5 | CAS number: 7786-17-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study pre-dates GLP and the standard guidelines; nevertheless, data is well summarised and the experiment is conducted in accordance with generally accepted scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Test conducted in accordance with FHSA principles.
- GLP compliance:
- no
Test material
- Reference substance name:
- 6,6'-di-tert-butyl-4,4'-thiodi-m-cresol
- EC Number:
- 202-525-2
- EC Name:
- 6,6'-di-tert-butyl-4,4'-thiodi-m-cresol
- Cas Number:
- 96-69-5
- IUPAC Name:
- 4,4'-sulfanediylbis(2-tert-butyl-5-methylphenol)
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 500 mg applied as a finely ground powder, moistened with water.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6
- Details on study design:
- Local dermal irritation was assessed using the prescribed numerical system:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) or eschar formation (injuries in depth) preventing erythema reading 4
Edema formation:
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (edges raised approximately 1 millimetre) 3
Severe edema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- score for 6 animals
- Time point:
- other: Mean score for 24, 48 and 72 hours
- Score:
- 0.9
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Intact and abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- score for 6 rabbits
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0.94
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- score for 6 rabbits
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0.94
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- score for 6 rabbits
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- score for 6 animals
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Abraded skin
Any other information on results incl. tables
Table 1 Summary of Results after Exposure
Animal Number |
Erythema |
Edema |
||||||||||||||||||
4 hours |
24 hours |
48 hours |
72 hours |
7 days |
4 hours |
24 hours |
48 hours |
72 hours |
7 days |
|||||||||||
I |
A |
I |
A |
I |
A |
I |
A |
I |
A |
I |
A |
I |
A |
I |
A |
I |
A |
I |
A |
|
1 2 3 4 5 6 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
1 1 1 1 1 1 |
1 1 1 1 1 1 |
1 1 1 1 1 1 |
1 1 1 1 1 1 |
1 1 0 1 1 1 |
1 1 0 1 1 1 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
0 0 0 0 0 0 |
I = Intact skin
A = Abraded skin
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test material is not classified in accordance with EU criteria.
- Executive summary:
The potential of the test material to cause primary skin irritation was assessed in the New Zealand Albino rabbit.
500 mg of the test material was applied as a finely ground powder moistened with water to the intact and abraded skin of 6 test animals, with exposure lasting for 24 hours. The animals were observed for 7 days.
Slight erythema was evident for the 72 hours following exposure. However these effects were completely reversed after 7 days. No edema was seen.
As a result of this, no classification is required in accordance with EU criteria under the conditions of this study.
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