Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
Early study, but reporting the main relevant details, No GLP, short report

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)
GLP compliance:
no
Remarks:
pre-dates GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: CFY strain
Sex:
male
Details on test animals and environmental conditions:
no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region
- Type of wrap if used: Al foil + waterproof plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm (40-50°C} dilute soap solution
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume): 6,7 mL/kg
- Concentration: 75 % suspension
- Constant volume or concentration used: yes
- For solids, paste formed: yes
Duration of exposure:
24 h
Doses:
5 000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
yes, concurrent vehicle

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Mortality:
None
Clinical signs:
shortly after dosing slight lethargy. One rat showed slight erythema on the fourth day of treatment only. This rat and another were observed to have small, raised, brown nodules on areas on the treated sites on the day after treatment only
Body weight:
Bodyweight increases were normal compared with the controls
Gross pathology:
Autopsy findings were normal

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute median lethal percutaneous dose (LD 50 ) to male rats of the test item was found to be: greater than 5000 mg/kg bodyweight.
Executive summary:

Ten male rats were treated with The test item at a dosage level of 5 g/kg bodyweight.

There were no mortalities. Signs of reaction to treatment, observed shortly after dosing, consisted of slight lethargy only, which persisted for three days. One rat showed slight erythema on the fourth day of treatment only. This rat and another were observed to have small, raised, brown nodules on areas on the treated sites on the day after treatment only. Bodyweight increases were normal compared with the controls. Autopsy findings were normal.

CONCLUSION: The acute median lethal percutaneous dose (LD 50 ) to male rats of gold 4 N was found to be: greater than 5000 mg/kg bodyweight.