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: Study conducted prior to GLP similar to OECD guideline 402 on the registered substance itself. The method is to be considered scientifically reasonable with minor deficiencies in documentation, and only one dose (no limit dose) was tested.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not applicable
GLP compliance:
no
Remarks:
test conducted prior to GLP implementation
Test type:
other: single dose application
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Substance type: pure substance
- Analytical purity: chemically pure

Test animals

Species:
rat
Strain:
other: Wistar-II
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann animal breeder (Kirchborchen, Paderborn district) and Gierlich animal breeder (Bochum)
- Weight at study initiation: 160-210g
- Housing: macrolon cages, Type III
- Diet (e.g. ad libitum): Altromin R Standard diets (Altromin GmbH, Lage/Lippe) ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
polyethylene glycol
Remarks:
400
Details on dermal exposure:
TEST SITE
- Area of exposure: skin of the backs
- Type of wrap if used: aluminium foil and wide ahhesive plaster strip

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/kg bw
- Concentration (if solution): 25% emulsion
Duration of exposure:
24 h
Doses:
500 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 500 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 500 mg/kg bw
Based on:
test mat.
Mortality:
No cases of death occurred.
Clinical signs:
No symptoms of poisoning appeared with the rats in the first 24 hours after the application or during the 14-day post-observation time.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
The study was conducted prior to GLP similar to OECD guideline 402 on the registered substance itself. The method is to be considered scientifically reasonable with minor deficiencies in documentation, and only one dose (no limit dose) was tested. Hence, the results can be considered at least as sufficiently reliable to assess the dermal oral toxicity in rats. Since the test item was only tested at a dose of 500 mg/kg, which does not correspond to the limit dose, and no effects were seen, there can no absolute conclusions be made regarding the substances definitive classification under the CLP Regulation. It can only be stated that the substance is relatively harmless as does not trigger classification as acute toxic Cat. III or higher.
Executive summary:

In an acute dermal toxicity study similar to OECD 402, two groups of each five male and female rats were dermally exposed to the test item in polyethylene glycol 400 for 24 hours to the skin on the backs at a dose of 500 mg/kg bw. Animals then were observed for 14 days.

 

No cases of death occurred and no symptoms of poisoning appeared with the rats in the first 24 hours after the application or during the 14-day post-observation time. A dermal LD50 >500 mg/kg therefore results for both sexes.

 

The test item is hence of low Toxicity.