Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
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): 4-Chlorobenzaldehyde
- Physical state: crystalline
- Analytical purity: technically pure
- Lot/batch No.: 2593

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeder Winkelmann, Borchen, Germany
- Weight at study initiation: 160-200 g
- Housing: Makrolon cages typ III
- Diet ( ad libitum): "Altromin R-Haltungsdiät"
- Water (ad libitum): yes


ENVIRONMENTAL CONDITIONS
- Temperature (°C): yes
- Humidity (%): yes
- Air changes (per hr): yes
- Photoperiod (hrs dark / hrs light): yes

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
peanut oil
Details on dermal exposure:
TEST SITE
- Area of exposure: shaved back skin
- coverage: wrapped


REMOVAL OF TEST SUBSTANCE
- Washing: after 24 h exposure rinsed with water and soap


TEST MATERIAL
- Amount applied: 8-10 drops in peanut oil, undiluted
Duration of exposure:
24 h
Doses:
males: 2500 or 5000 mg/kg bw
females: 1000, 2500 or 5000 mg/kg bw
No. of animals per sex per dose:
1000 or 2500 mg/kg bw : 5 animals
5000 mg/kg bw : 10 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
- 2/10 females in the high dose group died after 48 hours
Gross pathology:
- after necropsy of dead animals there were findings in lungs, liver, kidneys and spleen
- animals necropsied after 14 days observation period showed no signs of pathological changes in organs examined

Any other information on results incl. tables

Dose

[mg/kg bw]

Dead animals

Animals with symptoms

Animals treated

 

male

2500

0

0

5

5000

0

10

10

 

 

 

 

 

female

1000

0

0

5

2500

0

5

5

5000

2

10

10

Applicant's summary and conclusion

Executive summary:

In this acute dermal toxicity study groups Wistar rats were dermally exposed to p-Chlorobenzaldehyde (technical pure) in peanut oil at doses of 1000 (5 females), 2500 (5/sex) or 5000 mg/kg bw (10/sex) for 24 hours to the shaved back skin. Animals then were observed for 14 days.

Rats showed signs of toxicity until day 6 of the observation period.

Mortality occured in two out of 10 female animals of the highest dose group. After necropsy there were findings in lungs, liver, kidneys and spleen.

During terminal necropsy of surviving animals of all other groups no pathological changes were noted.

The LD 50 value was established to be > 5000 mg/kg bw for both sexes.