Registration Dossier
Registration Dossier
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EC number: 233-915-0 | CAS number: 10433-41-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: Chinese standard HJ/T154-2004
- GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium dimethyl 5-sulphonatoisophthalate
- EC Number:
- 233-915-0
- EC Name:
- Potassium dimethyl 5-sulphonatoisophthalate
- Cas Number:
- 10433-41-7
- Molecular formula:
- C10H10O7S.K
- IUPAC Name:
- potassium 3,5-bis(methoxycarbonyl)benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Sample lot: 100315
Source: Takemoto
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult, 12 weeks old
- Weight at study initiation: male: 2.4 and 2.6 kg, female: 2.4 and 2.5 kg.
- Housing: Bred in plastic breed box (L35 x W50 x H32 cm), one in a cage, cage changed twice a week.
- Diet (e.g. ad libitum): During the whole period, the animal is free to eat.
- Water (e.g. ad libitum): During the whole period, the animal is free to drink.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 23
- Humidity (%): 48 - 58
- Photoperiod (hrs dark / hrs light): simulates natural sunlight 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 72 h
- Observation period:
- 72 h
- Number of animals:
- 4
- Details on study design:
- Normal New Zealand White Rabbit, fine skin, 12 weeks old, weight 2.4 - 2.6 kg, 4 in number, each bred in a cage.
Fur in the back is shaved off 24 hr before testing, the area is 3 x 3 cm2. 0.5g of the sample is evenly spread out on a 2.5 x 2.5 cm2 2-layer guaze fabric rinsed by distilled water, placed on the left side of the exposed skin, and covered by a cellophane, fixed by a non-irritating adhesive tape and strapping in order to let the sample contact with the skin and prevent animal from licking.
The control group is the right side of the skin. The time for administration is 4 hr. After sample contact, remaining sample is washed away by warm water. After the sample is removed, the treated area is observed for 24, 48, 72 hr.
Skin reaction evaluated according to OECD 404-1 (2004). After the average score is calculated, the skin irritation level is evaluated according to OECD 404-2 (2004).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The highest average score for acute skin irritation test in rabbits for the sample is 0, therefore classified as not irritating.
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