Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
other: acute dermal toxicity study
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3-dichloro-4-nitrobenzene
EC Number:
210-248-3
EC Name:
1,3-dichloro-4-nitrobenzene
Cas Number:
611-06-3
Molecular formula:
C6H3Cl2NO2
IUPAC Name:
1,3-dichloro-4-nitrobenzene
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: 0.9 % saline
Duration of exposure:
24 h
Doses:
male rats: 2000 mg/kg bw.; female rats: 500, 800, 1000, 1250, 2000 mg/kg bw.
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
921 mg/kg bw

Any other information on results incl. tables

Mortality:

 male rats     female rats   
  Dose (mg/kg bw)  absolute  relative (%)  absolute  relative (%)
500  -  -  0/5
 800  -  - 2/5  40
 1000  -  -  2/5  40
 1250  -  -  5/5  100
 2000  4/5  80  5/5  100

LD50 (mg/kg bw.) 921

Applicant's summary and conclusion

Executive summary:

In an acute dermal toxicity study in male and female Wistar rats the LD50 was 921 mg/kg bw in female animals. Male rats did not react more sensitive. Doses up to 2000 mg/kg bw. were applied occlusively to the back skin of the rats. Mortality occurred mostly in the night. Symptoms observed were, unspecific symptoms and disturbed course of movement.. In one animal narrowed palpebral fissures were observed. One female animal of the 1250 mg/kg group showed pallidness of skin, drowsiness, diminuated startle reflexes and diminuated breathing frequency.

5 days after treatment all surviving animals were free of symptoms.

No bodyweight abnormalities were observed.

Died animals showed staining at liver, lung and spleen. In the killed animals no abnormalities were observed.

Regarding the LD50 of 921 mg/kg bw the test substance was found to be slightly toxic according to directive 83/467/EWG and therefore classified as R21.

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