Registration Dossier
Registration Dossier
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EC number: 201-956-3 | CAS number: 89-98-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 December 1984 to 21 December 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed study according to existing guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Remarks:
- according to OECD principles
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-chlorobenzaldehyde
- EC Number:
- 201-956-3
- EC Name:
- 2-chlorobenzaldehyde
- Cas Number:
- 89-98-5
- Molecular formula:
- C7H5ClO
- IUPAC Name:
- 2-chlorobenzaldehyde
- Details on test material:
- IUCLID4 Test substance: as prescribed by 1.1 - 1.4
- Name of test material (as cited in study report): o-Chlorbenzaldehyd D
- Storage condition of test material: in the dark, in a fume hood, 22°C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF
- Age at study initiation: no data
- Weight at study initiation: males: 162 g - 190 g (average 177 g); females: 161 g - 193 g (average 173 g)
- Fasting period before study: about 16 hours
- Housing: 5 animals per makrolon cage
- Diet: Altromin 1324 rat diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25%
MAXIMUM DOSE VOLUME APPLIED: 5, 8, 12.6, 20 ml/kg bw - Doses:
- 1250, 2000, 3150, 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology, histopathology
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 150 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- >= 3 150 - <= 5 000 mg/kg bw
- Mortality:
- see below
- Clinical signs:
- other: Decreased spontaneous activity, stupor, flanks pinched in, ataxic gait, squatting posture, prone position, ruffled fur, palpebral fissure narrow, panting, decreased respiration rate, mucilaginous feces. Clinical signs were reversible four days after ap
- Gross pathology:
- gross pathology of the animals which died:
stomach plump filled with food, yellowish to yellowish-green jelly mass in the small intestine, dark coloured adrenals, bladder plump filled, lung plethora;
no macroscopic findings in the animals which survived till the end of the study
Any other information on results incl. tables
mortality:
| mortality | ||||
| dose | males | females | ||
| mg/kg bw | absolut | relative (%) | absolut | relative (%) |
| 1250 | 0/5 | 0 | 0/5 | 0 |
| 2000 | 0/5 | 0 | 0/5 | 0 |
| 3150 | 1/5 | 20 | 2/5 | 40 |
| 5000 | 5/5 | 100 | 5/5 | 100 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information concluded by submitter Criteria used for interpretation of results: EU
- Conclusions:
- LD50 values for acute oral toxicity in male and female Wistar rats are between 3150 and 5000 mg/kg bw.
- Executive summary:
Acute oral toxicity of 2-chlorobenzaldehyde has been investigated in male and female rats (5 animals per sex per dose). LD50 values for male rats were between 3150 and 5000 mg/kg bw and about 3150 mg/kg bw for female rats.
This well performed guideline study, which was in accordance with GLP principles has been judged to be reliable without restrictions (RL1) and was selected as key study. The test item has not to be classified according to the criteria of the EU directive 83/467/EWG.
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