Cyclohexanone oxime

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Equivalent to guidellne with limited documentation

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

additional: haematology performed

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexanone oxime

EC Number:

202-874-0

EC Name:

Cyclohexanone oxime

Cas Number:

100-64-1

Molecular formula:

C6H11NO

IUPAC Name:

cyclohexanone oxime

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): cyclohexanone oxime
- Analytical purity: 99,5%

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Davidson Mill Farms, NJ, USA
- Acclimation period: at least 14 days

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

Exposure to back skin shaved 24 h prior to application

Duration of exposure:

24 h

Doses:

0, 0.8, 2 or 5 g/kg bw

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations: daily; weighing: days -14, -7, 0 (day of exposure), 1, 4, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: spleen weights determined at end of study, blood was taken on days 1, 4 and 7 and haematology was performed

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

approximate LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

not observed

Clinical signs:

not observed

Body weight:

not altered

Gross pathology:

no effects observed

Other findings:

- Organ weights: no effects on spleen weight
- Potential target organs: blood
- Other observations: haematology: dose-related increase in reticulocyte counts in both sexes, statistically significant only in males at highest dose, further effects: dose-related decrease in haemoglobin in females, significant at highest dose on day 7; dose-related increase in methaemoglobin in both sexes at day 4

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 dermal LD50 was > 5000 mg/kg bw. No classification is required.

Executive summary:

New Zealand white rabbits (5 per sex and dose) were tested for acute dermal toxicity in a study equilvalent to guideline OECD 402. They were exposed to 0, 800, 2000 or 5000 mg/kg bw of the test substance dermally for 24 h under an occlusive patch and observed for 14 days. No animal died at any dose level. There were no adverse clinical signs, body weight or organ weight changes associated with treatment. Haematological effects (all dose-related: increased reticulocyte counts, significant at highest dose only in in males; decreased haemoglobin values in females, significant at highest dose on day 7; increased methemoglobin levels in both sexes at day 4) indicate systemic uptake of the test substance.

Under the conditions of this study the dermal LD50 was > 5000 mg/kg bw.