Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Five male and five female Wistar rats received a single dose of 200, 356, 632, 1124, or 2000 mg/kg bw (male rats) and 200, 356, 474, 632, or 2000 mg/kg bw (female rats) of 1,8-naphtylendiamine per gavage. The animals were observed for mortality, body weights and clinical signs through day 14. A gross necropsy was performed on animals which died during the observation period or were sacrificed at the end of the 14 days observation period.
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
purity: 99.5%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1,2-propandiol
Doses:
male rats: 200, 356, 632, 1124, or 2000 mg/kg bw (
female rats: 200, 356, 474, 632, or 2000 mg/kg bw
No. of animals per sex per dose:
5 mael and 5 female rats/dose
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
591 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
>= 1 124 - <= 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

For male rats a LD50 in the range between 1124 and 2000 mg/kg bw was found, and for female rats a LD50 of 591 mg/kg bw was determined

As signs of intoxication in all dose groups sedation was observed. Some animals in the higher dose groups revealed, a poor general condition, polyurie and cyanosis. Body weight development was not affected, but one female rats had a body weight reduction in the 2nd week.

In the dose group of 474 to 2000 mg/kg bw, the stomach was filled with discolored liquid, stomach and intestines were stained.

some animals revealed a urinary bladder fileed with brownish-red liquid.. Two male animals killed at the end of the observation period had pale kidneys. All other animals had no pathological findings.

Applicant's summary and conclusion

Executive summary:

Five male and five female Wistar rats received a single dose of 200, 356, 632, 1124, or 2000 mg/kg bw (male rats) and 200, 356, 474, 632, or 2000 mg/kg bw (female rats) of 1,8-naphtylendiamine per gavage. The animals were observed for mortality, body weights and clinical signs through day 14. A gross necropsy was performed on animals which died during the observation period or were sacrificed at the end of the 14 days observation period.

For male rats a LD50 in the range between 1124 and 2000 mg/kg bw was found, and for female rats a LD50 of 591 mg/kg bw was determined

As signs of intoxication in all dose groups sedation was observed. Some animals in the higher dose groups revealed, a poor general condition, polyurie and cyanosis. Body weight development was not affected, but one female rats had a body weight reduction in the 2nd week.

In the dose group of 474 to 2000 mg/kg bw, the stomach was filled with discolored liquid, stomach and intestines were stained.

some animals revealed a urinary bladder fileed with brownish-red liquid.. Two male animals killed at the end of the observation period had pale kidneys. All other animals had no pathological findings.