Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study, no GLP; short report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
technically pure

Test animals

Species:
rabbit
Strain:
other: white Wiener
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BASF, Ludwigshafen, Germany
- Age at study initiation: no data
- Weight at study initiation: ca. 2,8 kg (mean)


- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
olive oil
Details on dermal exposure:
TEST SITE
- Area of exposure: 340 cm²
- Type of wrap if used: paper and textile

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration: 30 % (paste)
- Constant concentration used: yes
- For solids, paste formed: yes

VEHICLE
Olive oil
- Amount(s) applied (volume): ca 4 mL in treated and 8-9 mL in control

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
male treaded: 4
female treaded: 2
male untreaded: 1
female untreaded: 1
Control animals:
yes, concurrent vehicle
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs; other: local irritation effects

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
1 male animal died 10 days after treatment.
Clinical signs:
Temporary diarrhea, severe local blue discoloration by the test material.
One male showed reduced food uptake and degraded general condition before it died after 10 days.
No findings in control animals.
Body weight:
no data
Gross pathology:
Moderately reduced to completely missing perirenal fatty tissue.
In one animal perirenal fatty tissue was well developed with blue discoloration.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The aproximate lethal dose was above 2000 mg/kg bw in rabbits after dermal application for 24 hours.
Executive summary:

The acute dermal toxicity of the test material was determined in six rabbits. The material was applied at a dose os 2000 mg/kg bw (limit test) at a concentration of 30 % in olive oil und semiocclusive conditions for 24 hours. Animals developed temporary diarrhea and severe blue discoloration by the test material on the first day. One male animal died after ten days after showing reduced general condition and food uptake.

Controls did not show any effects.

The aproximate lethal dose was above 2000 mg/kg bw in rabbits after dermal application for 24 hours.