Registration Dossier
Registration Dossier
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EC number: 204-634-0 | CAS number: 123-54-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
- Principles of method if other than guideline:
- Undiluted 2,4-pentanedione was applied on the shaved dorsal skin (25 cm2) of 3-5 male or female New Zealand White rabbits/group (occlusive contact for 24 h; 14 d postapplication period; 5 doses).
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Details on test material:
- Purity: >99%
Physical state: yellow, transparent non-viscous liquid
Lot No.: 496-500
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Weight: 2-3 kg
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 25 cm2
TEST MATERIAL
- Amounts applied: 0.5 - 10 mL/kg bw
- Concentration: undiluted
- Constant volume or concentration used: no
- For solids, paste formed: no - Duration of exposure:
- 24 h
- Doses:
- Males: only in males 10 and 5 mL/kg bw, equivalent to 9700 and 4850 mg/kg bw
Males and females: 2, 1 and 0.5 mL/kg bw, equivalent to 1940, 970 and 485 mg/kg bw tested - No. of animals per sex per dose:
- 0.5, 1, 2 mL/kg bw: 5 males and 5 females
5 and 10 mL/kg bw: 3-5 males (not further specified) - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 370 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 780 - 2 420
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 790 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 570 - 1 090
- Mortality:
- No animal died within the lowest dose group, but 1/5 males and 4/5 females died in the 1 mL/kg dose group, 4/5 males and 5/5 females in the 2 mL/kg dose group and all males in the two highest dose groups of 5 and 10 mL/kg. Death occurred within 1-24 h after application.
- Clinical signs:
- other: Signs of toxicity at 1 mL/kg or more were: dilated pupils, salivation 10 mL/kg bw: convulsions; local erythema, edema and necrosis (persisted for 1-7 d) and scab formation at day 14.
- Gross pathology:
- Dead animals showed red mottled lungs, patchy congestion of tracheal mucosa, and a few stomachs with superficial black foci at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Under the evaluated conditions, LD50 values for male rabbits of 1370 mg/kg bw and females of 790 mg/kg bw were determined.
- Executive summary:
New Zealand White rabbits were dermally exposed under occlusive conditions to the test substance with the application of 2, 1 and 0.5 mL/kg bw, equivalent to 1940, 970 and 485 mg/kg bw tested to male and female rabbits (5/sex/dose). Additionally only in males 10 and 5 mL/kg bw, equivalent to 9700 and 4850 mg/kg bw were tested.
No animal died within the lowest dose group, but 1/5 males and 4/5 females died in the 1 mL/kg dose group, 4/5 males and 5/5 females in the 2 mL/kg dose group and all males in the two highest dose groups of 5 and 10 mL/kg. Death occurred within 1-24 h after application.
Signs of toxicity at 1 mL/kg or more were: dilated pupils, salivation
10 mL/kg bw: convulsions; local erythema, edema and necrosis (persisted for 1-7 d) and scab formation at day 14.No effect on bodyweight was observed in the surviving animals.
Dead animals showed red mottled lungs, patchy congestion of tracheal mucosa, and a few stomachs with superficial black foci at necropsy.
Under the evaluated conditions, LD50 values for male rabbits of 1370 mg/kg bw and females of 790 mg/kg bw were determined.
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