Registration Dossier
Registration Dossier
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EC number: 228-958-7 | CAS number: 6379-72-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Pre-guideline and pre-GLP study. Only basic data given but the study is comparable to OECD TG 401.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- no details test animals, environmental condition of animal room, body weight, pathology findings
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-prop-1-enylveratrole
- EC Number:
- 202-224-6
- EC Name:
- 4-prop-1-enylveratrole
- Cas Number:
- 93-16-3
- Molecular formula:
- C11H14O2
- Test material form:
- not specified
- Details on test material:
- None
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- 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
- Details on oral exposure:
- No data
- Doses:
- 2000, 2500, 3200, 4000 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs and mortality at least daily for 14 days.
- Necropsy of survivors performed: No data - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2 030 - <= 3 080
- Mortality:
- - 5/10, 6/10, 6/10, 9/10 and 10/10 animals died at 2000, 2500, 3200, 4000 and 5000 mg/kg bw, respectively.
- Clinical signs:
- other: - Immediate stimulation followed by ataxia was observed.
- Gross pathology:
- No data
- Other findings:
- None
Any other information on results incl. tables
Table 7.2.1.1 – Distribution of mortality
|
Observation day |
|||||||||||||
Dose (mg/kg bw) |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
2000 |
1 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2500 |
4 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3200 |
4 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4000 |
7 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5000 |
0 |
8 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Based on the available data, the substance is:
- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw
- classified as category 5 according to the GHS since rat Oral LD50 is lower than 5000 mg/kg bw (2500 mg/kg bw) - Executive summary:
In an acute oral toxicity study, performed similarly to OECD Guideline No. 401, groups of rats (10/dose) were administered a single oral dose of test material at 2000, 2500, 3200, 4000 and 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days.
5/10, 6/10, 6/10, 9/10 and 10/10 animals died at 2000, 2500, 3200, 4000 and 5000 mg/kg bw, respectively. Immediate stimulation followed by ataxia was observed.
Rat Oral LD50 = 2500 mg/kg bw (95 % confidence limits of 2030-3080 mg/kg bw)
Based on the available data, the substance is:
- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw
- classified as category 5 according to the GHS since rat Oral LD50 is lower than 5000 mg/kg bw (2500 mg/kg bw)
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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