Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
January 1976
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Results difficult to assess due to methodological deficiencies.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Only 1 or 2 animals per dosing level were used (instead of 5)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 1.8 - 2.1 kg; females: 1.8 - 1.9 kg

- No information on environmental conditions were provided.

IN-LIFE DATES: not indicated

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
794, 1000, 2000 and 3160 mg/kg bodyweight
No. of animals per sex per dose:
794 mg/kg bw: 1 female
1000 mg/kg bw: 1 male and 1 female
2000 mg/kg bw: 1 female
3160 mg/kg bw: 1 male
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 794 - < 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Due to the limited number of animals tested, no correct LD50 can be derived.
Mortality:
794 mg/kg bw: only 1 female animal exposed, no death occurred;
1000 mg/kg bw: 2 animals (1 male and 1 female) were exposed from which 1 male animal died at day 6.
2000 mg/kg bw: only 1 female exposed which died at day 2.
3160 mg/kg bw: only 1 male exposed which died at day 1.
Clinical signs:
Reduced appetite and activity (two to four days in survivors), increasing weakness and collapsing were observed.
Gross pathology:
In animals who died during the study lung, liver and kidney hyperemia, slightly enlarged gall bladder, darkened spleen and gastrointestinal inflammation were observed. In animals who were sacrificed after the 14 day observation period, viscera appeared normal.

Applicant's summary and conclusion

Interpretation of results:
other: EU CLP classification: Acute Dermal Toxicity Category 4: Harmful in contact with skin.
Remarks:
Though no correct LD50 can be drived, dermal toxicity is observed pointing towards EU CLP classification.
Conclusions:
Due to the limited number of animals tested (only one or two per dose), no correct LD50 can be derived. However, despite the limitations of the study it can be seen that the acute dermal toxicity (LD50) of the substance is very likely between 794 and 2000 mg/kg bw.
Executive summary:

In this study performed somewhat equivalent to OECD TG 402 guideline, 5 rabbits (2 males and 3 females) were exposed to the substance. Only 1 or 2 animals per dose were used at dose levels of 794, 1000, 2000 and 3160 mg/kg bw. At the lowest dose, no mortality was seen, at 1000 mg/kg bw one out of two animals died (in six days), at the two highest dose levels both animals died (in two days and one day, resp.). Reduced appetite and activity (two to four days in survivors), increasing weakness and collapsing were observed. In animals that died during the study lung, liver and kidney hyperemia, slightly enlarged gall bladder, darkened spleen and gastrointestinal inflammation were observed. Animals, which were sacrificed after the 14 day observation period, the viscera appeared normal. Due to the limited number of animals tested, no correct LD50 can be derived. However, despite the limitiations in study design it can be seen that the LD50 is very likely between 794 and 2000 mg/kg bw.