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Toxicological information

Acute Toxicity: oral

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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:
1985
Report Date:
1985

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
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
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
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 application.
Body weight:
not affected
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.