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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
March 12th, 1985 - March 26th, 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP - guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 79/831/EWG, Annex V, Part B
Deviations:
yes
Remarks:
analytical purity of test substance not given
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Glycerides, C16-18 and C18-hydroxy mono- and di-
- Batch No.: 4026-3
- Physical state: pellets
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann GmbH, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: average weights: males: 179 g, females: 143
- Fasting period before study: no data
- Housing: individually in Makrolon cages type II with soft wood bedding
- Diet (e.g. ad libitum): Altromin 1324, Lage, Germany.
- Water (e.g. ad libitum): tap water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 51
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: March 12th, 1985 - March 26th, 1985

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsum
- % coverage: 6 cm x 4 cm
- Type of wrap if used: gauze, polyethylen foil, leukosilk bandage and acrylastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h
Duration of exposure:
24 hours
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
- Frequency of observations: several times on day of application, thereafter twice a day
- Frequency of observations and weighing: before administration and on days 2, 7 and 14.
- Necropsy of survivors performed: yes, after 14 days from all treated animals
- Other examinations performed: daily skin examination

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: rat
Mortality:
None.
Clinical signs:
No signs of systemic toxicity were observed.
Body weight:
All animals showed the expected gain in body weight.
Gross pathology:
No abnormalities observed.
Other findings:
No local skin irritation observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU