Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 December 1988 to 27 February 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well documented guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Remarks:
OECD principles of Good Laboratory Practice (GLP)
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Chlorbenzaldehyd
- Stability under test conditions: stability guaranteed for the study duration
- Storage condition of test material: in a refridgerator in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Bor: WISW (SPF-Cpb)
- Source: Winkelmann, Borchen
- Age at study initiation: 2-3 month
- Weight at study initiation: about 170g to 210g
- Housing: 5 animals per cage
- Diet: Altromin 1324 - "Haltungsdiät für Ratten und Mäuse" ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): about 50%
- Air changes (per hr): about 10 times per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose/head only
Vehicle:
other: none
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: plexiglass tubes
- Exposure chamber volume: about 7 liters
- Method of holding animals in test chamber: exposure tubes were locked on one end in a way that the tail was outside of the tube
- Source and rate of air: 10-20 l/min
- Method of conditioning air: generation of compressed air and automatically conditioning
- System of generating particulates/aerosols: compressor
,- Temperature, humidity, pressure in air chamber: 24-25°C; 25-30%


TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography with FI-detector
- Samples taken from breathing zone: yes


VEHICLE: none


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: not applicable
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): not applicable

Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
50, 653, 1203 mg/m3
No. of animals per sex per dose:
5 animals per sex per dose in the treatment groups and 10 animals per sex in the control group
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: not clearly stated
- Frequency of weighing: before exposure, day 3, 7 and 14 post exposure
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations with special regard to the mucous membranes of the eyes and respiratory tract, general condition, respiration, cardiovascular system, behaviour, central-nervous disturbances, reflex-activity
Statistics:
- evaluation of the body weight differences was performed with ANOVA analysis of variance
- effects of the respiratory tract were analysed with the "Pairwise Fisher's Test" and "R x C Chi-Square Test"

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1 203 mg/m³ air
Exp. duration:
4 h
Mortality:
no animals died during exposure or post exposure period
Clinical signs:
other: No clinical symptoms were recorded in animals of the control and low dose group. All animals of the mid and high dose group showed clinical symptoms lasting up to 3 hours after exposure. The following symptoms were reported: slowed respiration, reddened n
Body weight:
not affected
Gross pathology:
no pathological findings

Any other information on results incl. tables

 analytical exposure concentration (mg/m3)  animals per group  animals which died  animals with clinical symptoms
 females  
 0  10  0  0
 50.1  5  0
 652.0  5  0  5
 1202.8  5  0  5
 males
 0  10  0  0
 50.1  5  0  0
 652.0  5  0  5
 1202.8  5  0  5

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information concluded by submitter Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study the LC50 of 2-chlorobenzaldehyde is greater than the maximal technical achievable concentration of 1203 mg/m3.
Executive summary:

Acute inhalation toxicity of 2-chlorobenzaldehyde has been investigated with male and female Wistar rats which were exposed for 4 hours towards 0, 50.1, 652.5 and 1202.8 mg/m3 (nominal concentrations). Exposure to 50 mg 2-chlorobenzaldehyde per m3 air was tolerated by all animals without any clinical symptoms of intoxication. At higher test concentrations a transient and slight irritation of the respiratory tract  (decreased respiration rate, reddened nose) as well as slight CNS effects  (decreased motility, piloerection) were observed. No macroscopically visible changes occurred in the lungs or in any other tissue and organ. No sex specific differences were observed.