Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study. Reliability changed from "1" to "2" according to ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)."

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
68515-73-1
Cas Number:
68515-73-1
IUPAC Name:
68515-73-1
Details on test material:
- Name of test material (as cited in study report): trade name
- Physical state: Brown liquid
- Analytical purity: No data
- Lot/batch No.: No data
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Clerco Research Farm
- Age at study initiation: No data
- Weight at study initiation: 2528-2979g
- Housing: Individually in wire mesh suspension cages
- Diet: Purina Laboratory Rabbit Chow, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10.02.1987 To: 25.02.1987

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST MATERIAL
- Amount applied (volume or weight with unit): 0.5 mL

Duration of exposure:
24h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
One female died during the observation period.
Clinical signs:
other: Clinical changes associated with the test material are as follows: 1. Fecal stains 2. Yellow area throughout the site 3. Emaciated (two animals) 4. Nasal discharge (three animals) 5. Lacrimation (one animal)
Gross pathology:
A gross necropy performed on the animal which died revealed the following:
1. Fecal stains
2. Discharge from the nose and mouth
3.- Lungs appeared reddened
4. Spleen appeared darkened
5. Stomach appeared white
6. Liver overed with an excessive amount of white spots

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU