Registration Dossier
Registration Dossier
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EC number: 213-590-1 | CAS number: 991-84-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981-02-02 to 1981-02-09
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (no data on test material purity, test site was covered by an occlusive dressing, exposure duration was 24 h)
- Qualifier:
- according to guideline
- Guideline:
- other: Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 Vol. 43, No. 163, Auguust 22, 1978
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol
- EC Number:
- 213-590-1
- EC Name:
- 2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol
- Cas Number:
- 991-84-4
- Molecular formula:
- C33H56N4OS2
- IUPAC Name:
- 2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol
- Details on test material:
- - Physical state: Solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bred and raised on the premises
- Weight at study initiation: 2 - 3 kg
- Housing: Individually in metal cages
- Diet: Standard rabbit food - NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: For a minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 14/10
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Shaved, one side intact, the other abraded
- Vehicle:
- other: polyethylene glycol (PAG 400) + saline (70 : 30 parts)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 50 % in vehicle - Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 days
- Number of animals:
- 3 each sex
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.
SCORING SYSTEM: According to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritant / corrosive response data:
- No signs of irritation during all time points.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance revealed no skin irritating potential.
- Executive summary:
The acute skin irritation / corrosion property of the test substance was determined in a study similar to OECD guideline 404 after single dermal administration to rabbits. 0.5 g of the test substance was prepared as 50 % suspension in polyethylene glycol and saline (70 : 30 parts) on a gauze patch (2.5 x 2.5 cm) and applied occlusively to the intact and abraded skin of 3 New Zeeland White rabbits of each sex for 24 hours. The skin reaction was appraised upon removal and during an observation period of 7 days on the basis of the Draize scoring system. Mean 24 - 48 - 72 hour scores were 0 for erythema and edema for the intact skin. In conclusion, the test substance revealed no skin irritating potential, even under more stringent conditions as required in the guideline.
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