Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Internal BASF method was used, which was in large part equivalent to methods described in OECD guideline 402
GLP compliance:
no
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): Hexandiol-1,6
- Test substance No.: 81/161

Test animals

Species:
rabbit
Strain:
Vienna White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M. GAUKLER, 6050 Offenbach, Germany
- Weight at study initiation: mean 2.9 kg (male), 3.2 kg (female)
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm, Muskator-Werke, 4000 Düsseldorf, Germany; ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped dorsal and lateral part of back and flanks
- Type of wrap if used: inert foil covered with adhesive tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water and/or water/lutrol mixture
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2500 mg/kg bw
- Concentration (if solution): 50%
- Constant volume or concentration used: yes
- For solids, paste formed: yes


VEHICLE
- Concentration (if solution): 0.5% CMC in water
Duration of exposure:
24 h
Doses:
2500 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 8 days
- Frequency of observations and weighing: daily observations, weighing prior to study begin
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, skin irritation, mortality

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Mortality:
no mortalities
Clinical signs:
- within 20 min: slight apathy in 1/5 female
- within 30 min: slight apathy in 1/5 male
- slight skin irritation in 1/5 males, which disappears after 5 days
- slight skin irritation in1/5 female after 24 h, which disappear within 48 h
Gross pathology:
no abnormalities found

Applicant's summary and conclusion

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