Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP condition

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Azo zinc complex Pigment - Melamine compound
IUPAC Name:
Azo zinc complex Pigment - Melamine compound
Test material form:
other: brown powder
Details on test material:
Molecular weight 615.79
Lot no.BOS 3479-3423
purity/content: 100 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: 7 weeks
- Weight at study initiation: males,206.6 g-215.0 g; females 209.7 g-229.2 g
- Fasting period before study: no data
- Housing: individually
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
CMC (carboxymethyl cellulose)
Details on dermal exposure:
The test substance was applied uniformly over an area which was approximately 10% of the total body surface area. Test substance were held in contact with the skin with a porous gauze dresssing and non-irritating tape throughout the 24-hour exposure period.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Details on study design:
The test substance (2000 mg/kg bw) was applied uniformly over an area which was approximately 10% of the total body surface area. Test substance were held in contact with the skin with a porous gauze dresssing and non-irritating tape throughout the 24-hour exposure period. The wrappings were removed at 24 hours after applicatiopn. the applied areas were washed out gently with distilled water. the animals were observed for clinical signs and mortality and changes of body weight over a period of 14 days.
Statistics:
statistical analysis were performed by comparing the treatment group and the control group. Variance of numerical data was checked by F-test; then the student t-test was conducted to determine the singnificant difference between two groups

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no clinical signs, no mortality, body weight gain, no findings at necropsy
Mortality:
No death occurred in all animals during the experimental period
Clinical signs:
clinical signs related with the substance wer not observed in any amimals during the observation period
Body weight:
all living animals showed the normal increase in body weight
Gross pathology:
In all animals there were no lesons caused by administration of test substance

Applicant's summary and conclusion

Executive summary:

Acute dermal toxicity was examined in male and female Sprague-Dawley rats in accordance with OECD TG 402 under GLP conditions.The test substance (2000 mg/kg bw) was applied uniformly over an area which was approximately 10% of the total body surface area. Test substance were held in contact with the skin with a porous gauze dresssing and non-irritating tape throughout the 24-hour exposure period. The wrappings were removed at 24 hours after applicatiopn. the applied areas were washed out gently with distilled water. the animals were observed for clinical signs and mortality and changes of body weight over a period of 14 days.

No mortality was observed in the present study. Clinical signs related with the substance were not observed in any animal during the observaion period. All tested animals showed normal gains in body weight. In all animals there were no necropsy findings caused by administration of test substance.

Based on these results the LD50 value was considered to be higher than 2000 mg/kg bw