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: Basic data given
Remarks:
(no details on study design and results provided)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: 4 New Zealand white rabbits were exposed to the test item for 24 h. Applied doses were 631, 1000 and 1580 mg/kg bw, group sizes were n=1, n=1 and n=2, respectively. The observation period was 14 days.
- Parameters analysed / observed: mortality, clinical signs, gross autopsy
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
-Lot/batch No.of test material: KL 1003

Test animals

Species:
rat
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
631, 1000, 1580 mg/kg bw
No. of animals per sex per dose:
631 mg/kg bw: 1 female
1000 mg/kg bw: 1 male
1580 mg/kg bw: 1 male and 1 female
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross autopsy

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 1 000 - < 1 580 mg/kg bw
Based on:
test mat.
Mortality:
Mortality was observed after topical application of 1580 mg/kg bw in 2/2 test animals within 2 days. No mortalities were noted at the mid and low dose.
Clinical signs:
Reduced appetite and activity (three to five days in survivors), increasing weakness, collapse and death were observed.
Gross pathology:
In decedents, lung and liver hyperemia, enlarged gall bladder, darkened kidney and spleen, and gastrointestinal inflammation were observed.
In survivors, viscera appeared normal after the end of the observation period of 14 days.

Any other information on results incl. tables

Dose
[mg/kg bw]
Toxicological results* Mortality (%)
Males    
631 0/0 ---
1000 0/1 0
1580 1/1 100
Females    
631 0/1 0
1000 0/0 ---
1580 1/1 100
LD50 >1000 < 1580 mg/kg
* first number = number of dead animals
 second number = number of animals used

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
CLP: Acute toxicity, Cat. 4, H312