Diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]

Acute Toxicity: oral

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report Date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(At test ending, the survivors were not subjected to necropsy and pathological examination. )

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Details on test material:

- Physical state: red powder
- Analytical purity: no data
- Lot/batch No.: 7/83
- No further data provided

Specific details on test material used for the study:

- Physical state: red powder
- Analytical purity: no data
- Lot/batch No.: 7/83
- No further data provided

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: CERJ, 53940 Le Genest.
- Weight at study initiation: 220 - 250 g for males; 170 - 200 g for females
- Fasting period before study: yes, 18 hours
- Housing: 10 animals per cage (Makrolon SAFI cages, 60 x 40 cm)
- Diet (e.g. ad libitum): UAR A04 Diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 °C
- Humidity (%): 40 - 60 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

- Concentration in vehicle: 25 g of test material in 100 mL vehicle
- Application volume:: 2 mL/100 g body weight

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were continuously observed for mortality and clinical symptoms; body weights were recored at test initiation (prior to treatment), on day 7 and on day 14 of observation.
- Necropsy and pathological examination were scheduled for animals found dead during the first 8 hours following treatment.
- No necropsy of survivors was scheduled.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: neither mortality nor clinical signs indicative of toxicity were observed during the 14-day observation period.

Mortality:

All animals survived.

Clinical signs:

Immediately following application, piloerection and apathy were observed; these symptoms however disappeared rapidly during the course of the observation period.

Body weight:

Body weight change in the course of the study was inconspicuous.

Gross pathology:

Since no animal died, no necrospy and thus, no gross pathology was conducted.

Any other information on results incl. tables

 Mean body weight recorded for male and female Wistar rats following single gavage with 5000 mg/kg bw of the test material:

Animals (N = 5/sex)		Day 0	Day 7	Day 14
Males	Treated	218.5 g	265.5 g	284 g
	Untreated*	231 g	267 g	290 g
Females	Treated	177 g	206 g	209 g
	Untreated*	190 g	207 g	207 g
Untreated*, vehicle only

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information