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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 February 1995 to 01 March 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to recent EU and OECD test guidance in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Reactive Blue FC 75311

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winklemann GmbH
- Age at study initiation: Males 8 - 10 weeks, Females 12 - 14 weeks
- Weight at study initiation: Inital mean weight: Males - 224g, Females - 199g
- Fasting period before study: No data
- Housing: Conventional conditions, Makrolon Type-II cages, invidually
- Diet (e.g. ad libitum): Altronim 1324 pellets, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10 - 15 per hours
- Photoperiod (hrs dark / hrs light): 12 hours light/dark (artifical light from 6am to 6 pm)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
castor oil
Remarks:
polyethoxylated (Cremophor EL)
Details on dermal exposure:
TEST SITE
- Area of exposure: Back & flanks
- % coverage: 10
- Type of wrap if used: non-irritant skin plaster (Fermoflexband)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Luke warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): No data
Duration of exposure:
24 hours
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
Males - 5
Females - 5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: Several times on the day of application then twice daily (once at weekends & bank holidays). Weighing: Directly before administration, after one week and at the end of the 14 day observation period.
- Necropsy of survivors performed: yes
Statistics:
Taking into consideration available data, the dosages are selected in such a way that graded lethality rates are obtained, which allow calculation or at least an estimate of the LD50.

Sufficient characterisation of acute dermal toxicity is reached as a rule, even if no substance-related lethality occurs at a dosage of 2000 mg/kg body weight.

The dosages are given in mg/kg body weight.

The following dosage was administered:

2000 mg/kg body weight

The calculation of the amount of test substance to be administrated was done taking into account a content of 65%.

Calculation of the Median Lethal Dose (LD50)

If calculation of the median lethal dose (LD50) is possible, it is done according to Spearman-Karher. The algorithm was adopted from SACHS, L. (Angewandte Statistik, 6.Auf1. 1984 , 178).

Should there be value pairs with a mortality of 0% and 100%, the geometric mean of the corresponding dosages is regarded as the "approximate LD50 value".

If only one dose group is used, the LD50 is estimated.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died during the 14-day observation period.
Clinical signs:
No signs of systemic poisoning were observed after single application of 2000 mg/kg body weight.

After the 21-hour exposure the skin in the area of the application site showed a blue discoloration in all rats. This coloration persisted until the 9th day of observation. All animals were free of signs from the 10th day.
Body weight:
Growth of male and female rats was not affected.
Gross pathology:
None of the animals sacrificed at the end of the 14-day observation period showed any noticeable gross pathological findings.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the present investigations, the test substance is therefore to be regarded as relatively non-toxic after acute dermal exposure.

LD50 > 2000 mg/kg body weight
Executive summary:

Study conducted to recent EU test guidance 92/69/EEC part B3 and OECD test guideline 402 in compliance with GLP.

Based on the study the test substance is to be regarded as relatively non-toxic after acute dermal exposure. The test substance is not classified.

LD50 > 2000 mg/kg body weight.