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Description of key information

In a study according to existing guidelines an oral LD50 of 3150 mg/kg has been established in female rats. No deaths were recorded in a guideline study on acute inhalative toxicity in rats which were exposed to vapour concentrations up to 1203 mg/m3 (technically maximal achievable concentration). No valid data on acute toxicity after dermal, intraperitoneal or intravenous application are available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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


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
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

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
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.

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 150 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
1 203 mg/m³
Quality of whole database:
Based on the results of this study the LC50 of 2-chlorobenzaldehyde is greater than the maximal technical achievable concentration of 1203 mg/m3.

Additional information

In a guideline conform study the LD50 after oral application was 3150 mg/kg for female rats and 3150 -5000 mg/kg for male rats. This study was selected as key study for the evaluation of acute toxicity after oral application (RL1). The findings of the key study are supported by three other studies of minor reliability (RL3 or RL4), which reported a little bit lower LD50 values (LD50 rat: 2160 or 2475 mg/kg).

Acute toxicity after inhalative exposure has been investigated in rats in a guideline conform study according to GLP principles (RL1). No deaths were recorded in rats exposed up to the technically maximal achievable concentration of 1203 mg/m3 for 4 hours.

Reliable data on acute toxicity after dermal, intravenous or intraperitoneal application are currently not available.

Justification for classification or non-classification

2-Chlorobenzaldehyde has not to be classified for acute toxicity according to EU principles.