Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

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

Test material

Constituent 1
Reference substance name:
Acid Violet 048
IUPAC Name:
Acid Violet 048

Test animals

Species:
rat
Strain:
other: CFY
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 232 to 268 g

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: on the day prior to treatment, hair was removed from the dorso-lumbar region of each rat with electric clippers. No shaving or chemical depilation was used.
- % coverage: an area equivalent to 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.

REMOVAL OF TEST SUBSTANCE
- Washing: treated area of skin was decontaminated by washing with warm (40 - 50 °C) dilute soop solution, rinsing in clean warm water and finally blotting dry with absorbent paper.
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Test solution: test item was prepared as a 50 % aqueous solution.
- Dosage volume: 10 ml/kg body weight.
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Ten males
Control animals:
yes, concurrent vehicle
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations: the areas of treated skin were examined daily for signs of local irritation. Any irritation was recorded numerically.
- Necropsy of survivors performed: all rats were sacrificed and examined macroscopically in an attempt to identify any target organs.

SCORING SYSTEM for IRRITATION
Erythema and eschar formation:
No eryrhema 0
Slight erythema 1
Well-defined erythema 2
Moderate erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema formation:
No oedema 0
Slight oedema 1
Well-defined oedema (area well defined by definite raising) 2
Moderate oedema (raised approximately 1 millimeter) 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) 4

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
There were no mortalities.
Clinical signs:
Signs of reaction to treatment consisted of slight lethargy only. No signs of irritation to the skin were seen during the fourteen days observation period.
Recovery of all animals, as iudged by external appearance and behaviour, was apparently complete within twenty-four hours of treatment.
Body weight:
The bodyweight increases of the treated animals resulted to be normal compared with controls.
Gross pathology:
Autopsy findings were normal.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
LD50 (male) > 5000 mg/kg bw
Executive summary:

The study was performed to assess the acute dermal toxicity of the test material in CFY rats. The test item was prepared as a 50 % aqueous solution and speaded over the prepared skin. The dose applied was 5000 mg/kg bw. On the day prior to treatment, hair was removed from the dorso-lumbar region of each rat with electric clippers; no shaving or chemical depilation was used. The treated area was then occlusively covered. Animals were observed over a period of 14 days after test item application.

No deaths occurred. Signs of reaction to treatment consisted of slight lethargy only. No signs of irritation to the skin were seen during the fourteen days observation period. Recovery of all animals, as iudged by external appearance and behaviour, was apparently complete within twenty-four hours of treatment. The bodyweight increases of the treated animals resulted to be normal compared with controls. Autopsy findings were normal.

Conlcusion

LD50 (male) > 5000 mg/kg bw