Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May I974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Acid Brown 098
IUPAC Name:
Acid Brown 098

Test animals

Species:
rat
Strain:
other: CFY
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 244 - 280 g

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- % coverage: 10 % of the total body surface
- Type of wrap if used: The treated area was then promptly covered with aluminium foil which was held in place with "Sleek" waterproof plaster encircled firmly round the trunk .

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): dosage volume of 6.7ml/kg bodyweight
- Concentration (if solution): 75% aqueous suspension
Duration of exposure:
24 hours
Doses:
0, 5000 mg/kg
No. of animals per sex per dose:
5 male rats
Control animals:
yes
Remarks:
Negative control
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: 1, 7 and 14 days
- Necropsy of survivors performed: yes, all rats were sacrificed and examined macroscopically in an attempt to identify any target organs.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD0
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
Signs of reaction to treatment consisted of slight lethargy only. No signs of irritation to the skin were observed during the two week observation period.
Gross pathology:
Normal autopsy findings.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation (EC n. 1272/2008)
Remarks:
Migrated information According to the CLP Regulation (EC n. 1272/2008) Criteria used for interpretation of results: EU
Conclusions:
LD0 = 5000 mg/kg bw
LD50 > 5000 mg/kg bw
Executive summary:

The substance has been tested for acute toxicity by dermal route according to a method similar to the one described in the OECD Guideline 402. Ten male rats are tested at the limit concentration of 5000 mg/kg b.w. Signs of reaction to treatment consisted of slight lethargy only. No signs of irritation to the skin were observed during the two week observation period.

Results

The acute median lethal percutaneous dose (LD50) to male rats was found to be greater than 5000 mg/ kg bodyweight. The substance is not classified according to the CLP Regulation (EC n. 1272/2008).