Registration Dossier
Registration Dossier
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EC number: 201-210-7 | CAS number: 79-50-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- (±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one
- EC Number:
- 201-210-7
- EC Name:
- (±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one
- Cas Number:
- 79-50-5
- Molecular formula:
- C6H10O3
- IUPAC Name:
- (±)-dihydro-3-hydroxy-4,4-dimethylfuran-2(3H)-one
- Details on test material:
- - Name of test material (as cited in study report): DL-Lacton (rein) = DL-alpha-Hydroxy-beta, beta-dimethyl-butyrolacton
- Molecular weight: 130.14
- Other: Identification number: Mag-No 4 2576 1
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Roche inbred strain
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Remarks:
- probably water
- Details on oral exposure:
- no data
- Doses:
- no data
- No. of animals per sex per dose:
- 5 - 10
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 10 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data - Statistics:
- no data
Results and discussion
- Preliminary study:
- no
Effect levelsopen allclose all
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 9 700 mg/kg bw
- Based on:
- not specified
- Remarks on result:
- other: standard deviation is 1600 mg/kg bw
- Sex:
- not specified
- Dose descriptor:
- other: LD 10
- Effect level:
- 6 200 mg/kg bw
- Based on:
- not specified
- Sex:
- not specified
- Dose descriptor:
- other: LD 90
- Effect level:
- 15 000 mg/kg bw
- Based on:
- not specified
Any other information on results incl. tables
- Table 1: Results after 24 h and 10 d post dosing
Lethal dose |
Time after gavage |
|
24 h |
10 d |
|
LD10, mg/kg |
6200 |
6200 |
LD50, mg/kg |
9700±1600 |
9700±1600 |
LD90, mg/kg |
15000 |
15000 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In an acute oral test, conducted comparable to OECD 401, the LD50 of RS-Pantolactone was determined to be 9700 ± 1600 mg/kg bw for the rat 10 d after application.
- Executive summary:
RS-Pantolactone (named DL-Lacton in the report) was tested for its acute oral toxicity comparable to OECD 401.
Rats were observed for 10 days after apllication.
The LD50 of the test item was determined to be 9700 ± 1600 mg/kg bw for the rat 24 and 10 d after application.
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