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Registration Dossier
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EC number: 701-140-1 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From November 23rd to December 14th, 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to internationally accepted testing guideline and following the GLP Principles.
- Justification for type of information:
- Justification for Read Across is detailed in the endpoint summary and it is further detailed in the report attached to the IUCLID section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Similar substance 01 of Acid Brown 191
- IUPAC Name:
- Similar substance 01 of Acid Brown 191
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf/Switzerland
Age at study initiation: (♂) 11 weeks, (♀) 13 weeksWeight at study initiation: (♂) 256 - 282 g; (♀) 199 - 213 g
Housing: individually in Makrolon type-2 cages with standard softwood bedding
Diet (ad libitum): Ad libitum Pelleted standard Kliba 343, Batch 31/88 rat maintenance diet
Water: ad libitum community tap water from Itingen
Acclimation period: at least one week under laboratory conditions after veterinary examinations
ENVIRONMENTAL CONDITIONS
Temperature: 22 ± 3 °CHumidity (%): 40 - 70 %Air changes (per hr): 10 - 15
Photoperiod (hrs dark / hrs light): 12/12 (during the light period: music)
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
Area of coverage: 10% of the total body surface
Type of wrap if used: occlusive dressing, wrapped around the abdomen and fixed with an elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
Washing: the treated skin was washed with lukewarm tap water, dried with disposable towels.
Time after start of exposure: 24 hours
TEST MATERIAL
Amount(s) applied (volume or weight with unit): 4 ml at concentration of 2000 mg/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 15 days
Frequency of observations and weighing:
Mortality/viability: Four times during test day 1 and daily during days 2 - 15
Body weights: Test day 1 (pre-administration), 8 and 15
Symptoms: each animal had an examination for changes in appearance and behaviour four times during day 1, and daily during days 2 - 15
Necropsy of survivors performed: yes - Statistics:
- The LOGIT-model could not be applied to the observed rate of death. the toxicity was estimated without use of a statistical model.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- not specified
- Mortality:
- No death occurred
- Clinical signs:
- other: At the dose of 2000 mg/kg bw the following signs were observed: Erythema, Brown discolored application area Scales (females)
- Gross pathology:
- No macroscopic organ changes have been observed
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as harmful/toxic according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- LD50 > 2000 mg/kg bw
- Executive summary:
Method
The test has been conducted according to the OECD Guideline 402 and to the EU Method B.3.
A limit test has been conducted on 5 male and 5 female rats using the single dose of 2000 mg/kg bw.
Observations
During the test no death occurred, no variations in the normal increase of the body weight and no macroscopic organ changes have been observed.
Result
The LD50 of the test item is greater than 2000 mg/kg bw.
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