Chromium, 3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonic acid complex

Acute Toxicity: dermal

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 following official guideline not GLP compliant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Black 52

IUPAC Name:

Acid Black 52

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

Source: breeding farm VELAZ
Sex: males
Acclimatisation: minimum 5 days
Total number: 5
Housing: animal room with monitored conditions-5 animals in one plastic breeding cage Velaz T4
Diet: standard pelleted diet
Water: drinking tap water ad libitum
Microclimatic conditions: room temperature 22 +/- 3°C permanently monitored
relative humidity 30-70% permanently monitored
light: 12 hours light/12 hours dark
Bedding: sterilized shavings of soft wood
Randomisation: according to the internal rule, at the start of the study the weight variation of animals was minimal and did not exceed +/- 20% fi the mean weight for each sex
Identification of animals: colour marks 1-5 on tail of animals, each cage was marked with the number of study, sex and dose of the test substance
Health conditions: certificate of good health condition-from breeding farm; no signs of diseases were observed at clinical check-in, during the acclimatisation period and before the strat of study

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: moistened with water pro-injection

Details on dermal exposure:

The amount of the test substance for each animal was weighed 8according to its body weight) and moistened with water for injection immediately before application.
Aproximately 24h before application the fur on the back of animals was shaved at area about 6x6 cm. Aliquot part of the test substance was applied on the depilated area of skin. The application site was covered by mull, plastic foil and held in contact by plaster (strapping). After 24h the occlusive dressing and the remains of test substance were removed.

Duration of exposure:

24h

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males

Control animals:

no

Details on study design:

BODY WEIGHT RECORDING
Animlas were weighed before application, at day 8 and before euthanasia of animals. Average body weight in a group was calculated from individual weights.

CLINICAL EXAMINATIONS
After application the animals were observed individually
1st day: at 30 min and 3h
2nd day: in the morning and in the afternoon
up to 14th day: once daily
Observations included: changes in the skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system.

PATHOLOGICAL EXAMINATION
All the test animals that survived to the end of the study were sacrificed on the 15th day and gross necroscopy was performed. Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: No clinical signs

Gross pathology:

All animals were without patho-morfological signs

Applicant's summary and conclusion

Interpretation of results:

other: not classified under Regulation 1272/2008

Conclusions:

The substance was tested for acute toxicity dermal, in a limit test, following OECD 402. The LD50 (LD0) was found to be equal to 5000 mg/kg bw

Executive summary:

The substance was tested for acute toxicity dermal, in a limit test, following OECD 402. The LD50 (LD0) was found to be equal to 5000 mg/kg bw