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EC number: 459-270-7 | CAS number: 2568-33-4 MBD
Toxicological information
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 May - 15 June 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Acute Dermal Toxicity (2-1-2) Nohsan No. 8147
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3-methyl-1,3-butandiol
- EC Number:
- 459-270-7
- EC Name:
- 3-methyl-1,3-butandiol
- Cas Number:
- 2568-33-4
- Molecular formula:
- C5 H12 O2
- IUPAC Name:
- 3-methylbutane-1,3-diol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Appearance: Clear, colourless liquid
Storage conditions: Room temperature in the dark
Lot number: 52834
Expiry: December 2006
Purity: >98%
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approximately eight to twelve weeks of age
- Weight at study initiation: 221 to 365 g
- Housing: metal cages suspended in mobile stainless steel racks
- Acclimation period:seven days
- Diet: ad libitum
- Water: ad libitum
- Environmental enrichment: small soft white untreated wood blocks during the acclimatisation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23°C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0600 - 1800 hours GMT) in each 24-hour period
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10% of the total body surface area
- Type of wrap if used: porous gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water (30 - 40°C)
- Time after start of exposure: end of 24 hours exposure period
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bodyweight - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Days 1 (prior to dosing), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: The macroscopic appearance of all tissues was recorded.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: No deaths occurred and no signs of toxicity were observed.
- Gross pathology:
- Effects on organs:
No abnormalities were noted in any animal at the macroscopic
examination at study termination on Day 15. - Other findings:
- Signs of toxicity (local):
No signs of toxicity or dermal irritation were observed.
Bodyweight gain was reduced in two females on Day 8 and for
one female on Day 15.
Bodyweight was satisfactory in all other animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute lethal dermal dose to rats of the test item was demonstrated to be greater than 2000 mg/kg bodyweight.
The test substance is in Category 3 according to the EPA Health Effects Test Guidelines OPPTS 870.1000 Acute Toxicity testing EPA 712-C-98-189 August 1998.
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