N-(trans-4-Hydroxycyclohexyl)-3,5-dibromo-2-hydroxybenzylidenamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

2,4-dibromo-6-({[(1r,4r*)-4-hydroxycyclohexyl]imino}methyl)phenol

EC Number:

924-083-6

Molecular formula:

C13 H15 Br2 N O2

IUPAC Name:

2,4-dibromo-6-({[(1r,4r*)-4-hydroxycyclohexyl]imino}methyl)phenol

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

300 and 2000 mg/kg

No. of animals per sex per dose:

3

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 300 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Two and four animals treated at 2000 mg/kg were found dead on test days 3 and 4,
respectively. All 300 mg/kg treated animals survived until the end of the study period.

Clinical signs:

Slightly ruffled fur was observed in five out of 6 animals treated at 2000 mg/kg between test
day 2 and 4 and hunched posture was noted in one animal of the same dose group on test
day 3, before they were found dead. No clinical signs were observed in the 300 mg/kg
treated animals during the course of the study.

Body weight:

The body weight of the animals was within the range commonly recorded for this strain and
age.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The median Iethal dose of NA 1523 after single oral administration to female rats, observed over a period of 14 days is:
300 mg/kg body weight < LD50 (female rat) < 2000 mg/kg body weight

Executive summary:

Twelve female HanBrl: WIST (SPF) rats were treated with NA 1523 by oral gavage administration at dosages of 2000 mg/kg or 300 mg/kg body weight. The test item was diluted in vehicle (purified water) at concentrations of 0.2 g/ml or 0.03 g/ml and administered at a volume dosage of 10 ml/kg.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded twice daily during test days 1-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

The following animals were treated and percentage of mortality was observed:

2000 mg/kg 1 00 %

300 mg/kg 0 %

Two and four animals treated at 2000 mg/kg were found dead on test days 3 and 4, respectively. All 300 mg/kg treated animals survived until the end of the study period.

Slightly ruffled fur was observed in five out of 6 animals treated at 2000 mg/kg between test day 2 and 4 and hunched posture was noted in one animal of the same dose group on test day 3, before they were found dead. No clinical signs were observed in the 300 mg/kg treated animals during the course of the study.

The body weight of the animals was within the range commonly recorded for this strain and age.

No macroscopic findings were recorded at necropsy.