Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate

Acute Toxicity: dermal

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Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

Directive 84/449/EEC

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: bulk

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain specifics: Hoe: WISKf (SPF71)
- Source: Hoechst AG breeding colony
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: male 184 g - 190 g (mean 187 g), female 192 g - 200 g (mean 195 g) on day 1 (treatment)
- Fasting period before study: approximately 16 hours before treatment, access to water permitted
- Housing: in groups of five in Makrolon type 3 cages with standard softwood bedding
- Diet (e.g. ad libitum): standard rat diet (Altromin 1324), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on dermal exposure:

On the day before treatment the back and flanks of each animal were clipped free of hair.
Using available information on the toxicity of the test item, a group of five male and five female rats was treated with the test item at a dose level of 2000 mg/kg.
1.0 g test item was mixed with 2.0 mL PEG 400. The appropriate amount was spread over a 6 x 8 cm aluminium foil and applied to an area of shorn skin. A piece of surgical gauze was placed over the treatment area and semi occluded with a piece of self adhesive bandage.

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

Before treatment the back of each animal were clipped free of hair (approx. 30 cm2)

Using available information on the toxicity of the test item, a group of five male and five female rats was treated with the test item at a dose level of 2000 mg/kg.

The test item was mixed with PEG 400. The appropriate amount was spread over a 6 x 8 cm aluminium foil and applied to an area of shorn skin. A piece of surgical gauze was placed over the treatment area and semi occluded with a piece of self adhesive bandage.


After the 24 hour contact period the bandage was carefully removed and the treated skin was washed with lukewarm water to remove any residual test item.

The animals were observed for deaths or overt signs of toxicity ½, 1, 2, 4 and 6 hours after dosing and subsequently once daily for fourteen days.

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity. Treated skin was yellow discoloured one day after administration.

Gross pathology:

No abnormalities were noted at scheduled necropsy.

Other findings:

Yellow coloured staining was noted at the test sites one day after administration.
There were no signs of dermal irritation noted.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.

Executive summary:

Male and female rats were subjected to test acute dermal toxicity according to OECD 402 (limit test). The test item was administered at one dose level of 2000 mg/kg bw to 5 male and 5 female rats by dermal application of the test item to intact skin. During the 14 days observation period no animals died and there were no abnormalities found in necropsy. There were no signs of systemic toxicity and animals showed expected gains in body weight over the study period except one male with 4 % body weight loss.

LD50 > 2000 mg/kg bw.

Therefore, the test item has not to be classified for acute dermal toxicity or specific target organ toxicity – single exposure, according to Regulation (EC) No 1272/2008.