A mixture of: N-(4-chlorophenyl)-4-(2,5-dichloro-4-(dimethylsulfamoyl)phenylazo)-3-hydroxy-2-naphthalenecarboxamide; N-(4-chlorophenyl)-4-(2,5-dichloro-4-(methylsulfamoyl)phenylazo)-3-hydroxy-2-naphthalenecarboxamide

Acute Toxicity: dermal

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:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffo-Credo, B.P. 0109 (69592 L'Arbresle Cedex - France)
- Age at study initiation: 5 to 7 weeks
- Weight at study initiation: 200 to 300 g
- Housing: in on air-conditioned building, individually in polycarbonate cages type FI (305 x 180 x 184 mm).
- Diet (e.g. ad libitum): pelleted complete Diet (rat -mouse Diet), ad libitum
- Water (e.g. ad libitum): filtered mains drinking water, ad libitum
- Acclimation period: 5 days minimum between animal arival and start of treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C (target range)
- Humidity (%): 30 to 70 % RH (target range)
- Air changes (per hr): minimum 8 air changes per hour

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE
- Area of exposure: not be less than 10 % of the total body surface
- Type of wrap if used: semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped clean of residual test article using water or other convenient means
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 29.69 % (W/V) in the vehicle (forming a paste)
- For solids, paste formed: yes

Duration of exposure:

24 h

Doses:

once 2000 mg/kg bw in corn oil (29.69 % W/V)

No. of animals per sex per dose:

5 males / 5 females

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Examinations for mortality and abnormal clinical signs were performed 15 minutes after application, then at 1, 2 and 4 hours, and then daily for the 14 day study period. Cutaneous examinations were performed from day 2 to 15.
- Frequency of weighing: D1, D8, D15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: No changes in behaviour or clinical signs in any of the treated animals during the observation period.

Gross pathology:

There were no macroscopic findings that could be associated with treatment.

Other findings:

No oedema and erythema were noted to the application site of the test article during the observation period (reading of the erythematous lesions were impossible from Day 2 to Day 5 because of a reddish colour observed to the cutaneous fur). Desquamation was noted on Days 6 and 7.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was estimated to be >= 2000 mg/kg bw for male and female rats.

Not subject of classification and labelling

Executive summary:

The test article was applied, once only as a paste in corn oil at a dose level of 2000 mg/kg, by the cutaneous route, in the Sprague- Dawley rat (5 males + 5 females). Examinations for mortality and abnormal clinical signs were performed 15 minutes after application, then at 1, 2 and 4 hours, and then daily for the 14 day study period. Cutaneous examinations were performed from day 2 to 15. All the animals were weighed immediately before application of the test article (Day 1), on Days 8 and 15. A necropsy was performed for all the animals after the final in vivo observation on Day 15.

There were no changes in behaviour or clinical signs in any of the treated animals during the observation period.

No oedema and erythema were noted to the application site of the test article during the observation period. Desquamation was noted on Days 6 and 7.

Body weight changes in the treated animals were not influenced by treatment.

At necropsy there were no macroscopic findings that could be associated with treatment.

The LD50 was estimated to be >= 2000 mg/kg bw for male and female rats.