Salts of 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthenium chloride and 4-{[1-hydroxy-6-({[5-hydroxy-6-(phenyldiazo)-7-sulfonaphthalen-2-yl]carbamoyl}amino)-3-sulfonaphthalen-2-yl]diazo}benzoic acid (2:1)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2008-03-20 to 2008-04-03

Reliability:

1 (reliable without restriction)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

rat, Wistar Crl:(WI)BR (SPF-Quality)
Male and female (nulliparous, non pregnant)
Number of animals: 5 animals/sex
Acclimatisation time: 8 days

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test item was applied as a single dose uniformly over an area of approximately 10 % of the total body surface for a 24-hour exposure period. Test item was administered in its original form, it was pulverised and was moistened sufficiently with water to ensure good contact with the skin. Sterile gauze pads were placed on the skin of the rats and kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semiocclusive plastic wrap for 24 hours. At the end of the exposure period, residual test item was removed using water at body temperature.

Duration of exposure:

24 hours

Doses:

The test item was administered in a single dose of 2000 mg/kg bw.

No. of animals per sex per dose:

5 animals

Control animals:

not required

Details on study design:

not applicable

Statistics:

not applicable

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality observed.

Clinical signs:

No clinical signs observed. Behaviour and physical condition of animals were considered to be normal.

Body weight:

The mean body weight and the body weight gain of the male and female animals were considered to be normal during the two-week observation period, similar to the expected values in untreated animals of the same age and strain.

Gross pathology:

No macroscopic alterations due to the effects of the test item were found. Gross necropsy revealed pale raised areas (2/5 male; 2/5 female) and pinprick-sized haemorrhages (3/5 male, 3/5 female) in the lungs due to the method of anaesthesia and exsanguination, which are also observable in untreated animals after anaesthesia. Two animals showed hydrometra related to the sexual cycle and which is a frequent observation in experimental rats.

Other findings:

Due to the colour of F 213 Red, 2000 mg/kg bw of the test item caused red colouration of the skin. Skin recovered 11 days after the patch removal. The alteration thus being temporary, therefore considered not toxicologically relevant.

Any other information on results incl. tables

no remarks

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 value of F 213 Red is greater than 2000 mg/kg bw in male and female CRL: (WI) BR rats. F 213 Red does not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC for classification and labelling of dangerous substances.

Executive summary:

Under the conditions of the present study, a single 24-hour dermal administration of 2000 mg/kg bw of the test item, F 213 Red caused no toxic changes on the treated skin. Mortalities were not observed, neither in male nor in female CRL:(WI)BR rats. This acute toxicity study by the dermal route did not indicate skin irritation at the limit dose level of 2000 mg/kg body weight tested. The acute dermal LD50 value of F 213 Red is greater than 2000 mg/kg bw in male and female CRL: (WI) BR rats. F 213 Red does not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC for classification and labelling of dangerous substances.