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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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.