1,8-naphthylenediamine

Acute Toxicity: oral

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

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

Test material information

Constituent 1

Reference substance name:

1,8-naphthylenediamine

EC Number:

207-529-8

EC Name:

1,8-naphthylenediamine

Cas Number:

479-27-6

Molecular formula:

C10H10N2

IUPAC Name:

naphthalene-1,8-diamine

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 levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

591 mg/kg bw

Based on:

test mat.

Effect levels 2

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.