Registration Dossier
Registration Dossier
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EC number: 700-408-5 | CAS number: 103429-90-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-07-02 to 1992-07-16
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Although a good quality report and conducted to GLP and documented test parameters are based on specific national guidelines, the purity of test substance is not reported and actual guidelines refs not quoted in test report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- No official test guidelines were cited, although on review of the test report, the methodology used was broadly consistent with OECD test guideline 402.
- GLP compliance:
- yes
- Remarks:
- The test report includes a statement of GLP compliance signed by the Study Director, and a statement of Quality Assurance, however no certificate of GLP compliance issued by an independant body (such as an official GLP monitoring authority) was included.
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3-Methoxy-3-methylbutyl acetate
- EC Number:
- 700-408-5
- Cas Number:
- 103429-90-9
- Molecular formula:
- C8H16O3
- IUPAC Name:
- 3-Methoxy-3-methylbutyl acetate
- Details on test material:
- - Name of test material (as cited in study report): MMB-Ac
- Physical state: Colourless liquid
- Lot/batch No.: 32840
- Storage condition of test material: Stored in the dark, under ambient conditions.
- Other: Specific gravity = 0.96
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- 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: males: 9-10 weeks; females: 11-12 weeks
- Weight at study initiation: males: 259-287 g; females:225-256 g
- Fasting period before study:
- Housing: housed by sex in polypropylene cages with mesh floors suspended over absorbent paper lined trays with maximum 5 animals per cages
- Diet: ad libitum
- Water: ad libitum)
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Mean Relative Humidity (%): 48
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- Area % - 10
- Type of wrap if used: gauze dressing (5x5 cm)
REMOVAL OF TEST SUBSTANCE
- Washing: skin was wiped with a water dampened tissue
- Time after start of exposure: 24 h
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- 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: frequently on the day of dosing and once daily for 14 days following dosing; Animals were weighted immediatey prior to doing, 7 days after dosing and at sacrifice at the end of the 14 day observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: red nasal discharge 4 hours after dosing; low body weight gains for females
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortalities and no abnormal clinical signs were observed in any of the 5 males and 5 females dosed.
- Mortality:
- No moralities
- Clinical signs:
- Red nasal discharge 4 hours after dosing
- Body weight:
- Low body weight gains for females
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Median Dermal Lethal Dose (LD50) of MMB-Ac in rats is greater than 2000 mg/kg.
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