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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP, only males were treated

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- purity: 99 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: obtained from breeder Winkelmann
- Weight at study initiation: 160 - 180 g
- Housing: 5 animals per caqge, SPF

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Lutrol
Doses:
600, 700, 800, 900, 1000 or 1200 mg/kg bw
No. of animals per sex per dose:
- 10 male rats per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
LD50 was calculated according to Fink an dHund, Arzneim.-Forsch. 15, 624 (1965).

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
840 mg/kg bw
Based on:
test mat.
95% CL:
780 - 910
Mortality:
see "any other information on results incl. tables"
Clinical signs:
All animals receiving more than 600 mg/kg bw showed clinical symptoms.
The symptoms included poor general state, diarrhoea, bloody nose, sedation or epistaxis.
Body weight:
no data
Gross pathology:
no data
Other findings:
see table below

Any other information on results incl. tables

Mortality:

Dose

[mg/kg bw]

Time of death

dead animals

animals with symptoms

treated animals

 

 

 

 

 

600

-

0

0

10

700

3 h

3

10

10

800

2 d

3

10

10

900

2 d

5

10

10

1000

2 d

9

10

10

1200

3 h

10

10

10

Applicant's summary and conclusion

Executive summary:

In a acute oral toxicity study (Bayer AG, Department of Toxicology, 1979), groups of young adult Wistar rats (10 males per group) were given a single oral dose of  p-Chlorobenzaldehyde (99 % a.i.) in Lutrol at doses of  600, 700, 800, 900, 1000 or  1200  mg/kg bw and observed for 14 days.

 

The oral LD50 value was established to be 840 mg/kg bw.