Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 May 1996 to 30 May 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid (unspecified)
Details on test material:
- Appearance: dark liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Hra: (NZW) SPF.
- Age at study initiation: 13 to 14 weeks.
- Weight at study initiation: 2.132 to 2.640 kg.
- Fasting period before study: No.
- Housing: Rabbits were housed individually in stainless steel cages.
- Diet (e.g. ad libitum): Rabbit Lab Diet, checked daily and added or replaced as needed.
- Water (e.g. ad libitum): Fresh water, ad libitum.
- Acclimation period: Animals were acclimated for a minimum of 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 26 °C.
- Humidity (%): 40 to 70 %.
- Photoperiod (hrs dark / hrs light): Light cycle of 12 hours light, 12 hours dark.

IN-LIFE DATES: From: 16 May 1996 To: 30 May 1996

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Preparation of area of exposure: Approximately 24 hours before testing, fur was clipped from the dorsal area of the trunk of the test animals. The test material was applied directly onto the exposed intact skin, taking care to spread it evenly over the entire area.
- Type of wrap if used: A square gauze patch was placed on the animals to cover the dosed area. The test site was then covered with rubber sheeting, wrapped with an elastic bandage and held in place with non-irritating tape to retard evaporation.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were recorded daily through Day 14. Bodyweights were recorded at initiation and on Days 7 and 14.
- Necropsy of survivors performed: yes. All rabbits were sacrificed by a lethal injection on Day 14 and a gross necropsy 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 was no mortality during the study.
Clinical signs:
No clinical signs were observed during the study.
Body weight:
There was an increase in mean bodyweight during the study.
Gross pathology:
No visible lesions were observed in any animal at terminal necropsy.
Other findings:
Erythema and/or oedema of the skin were observed at the application site on days 1 through to 5.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the LD50 was found to be >2000 mg/kg bw in male and female rabbits and therefore requires no classification in accordance with EU criteria.
Executive summary:

The potential of the test material to cause acute toxic effects when administered by the dermal route was investigated in a test using a method equivalent to those set out in the OECD 402 and EU Method B.3 guidelines. The test was conducted under GLP conditions.

The test material was administered once dermally to 5 male and 5 female New Zealand White rabbits at a limit dose of 2000 mg/kg bw. The test material applied undiluted and the animals were exposed for 24 hours.

There was no mortality and no systemic effects related to administration of the test material. Erythema and/or oedema of the skin were observed at the application site on days 1 through to 5. All animals appeared normal at necropsy. Mean body weights of the animals increased over the duration of the study.

Under the conditions of this study the LD50 was found to be >2000 mg/kg bw in male and female rabbits and therefore requires no classification in accordance with EU criteria.