Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
other: read across from analogue substance
Adequacy of study:
weight of evidence
Study period:
17. Apr 1974 - 02. May 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1976

Materials and methods

Principles of method if other than guideline:
BASF-Test. The study was performed according to: Noakes D.N. and Sanderson D.M., A Method for Determining the Dermal Toxicity of Pesticides. Brit. Journ. Ind. Med. 26, 59, 1969.
5 animals were treated for 4 or 24 h using occlusive conditions. An application site of 50 cm² was covered with the test substance and the trunk of the rat was encircled with a strip of plaster (2 layers). After the exposure time the skin was washed with detergent and water. The animals were observed 8 days and skin changes were recorded daily.

GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Similar Substance 2
IUPAC Name:
Similar Substance 2
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: WIGA
- Weight at study initiation: male: 144g (mean); female: 134g (mean)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 cm²

REMOVAL OF TEST SUBSTANCE
- Washing: After the exposure time the skin was washed with detergent and water.

TEST MATERIAL
- Concentration (if solution): 100%
- Constant concentration used: yes

Doses:
5 ml/kg (equivalent to 5000 mg/kg)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Animals were weighted prior to exposure and symptoms were recorded daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: see overall remarks.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 850 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality was observed.
Clinical signs:
other: No abnormal clinical signs could be observed. All animals obtained local staining (brown) from residual substance.
Gross pathology:
No abnormalities were noted at necropsy.

Any other information on results incl. tables

Mortality:

 Dose:  sex:  1h  24h  48h  7 days  14 days
 5  ml/kg  male   0/5   0/5   0/5   0/5   0/5
 5 ml/kg  female   0/5   0/5   0/5   0/5   0/5

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the available data the tested substance has no concern for acute dermal toxicity. Since the active substance in the tested sample is only 17% the LD50 dermal calculated on the active substance is 850 mg/Kg bw