9-Octadecenoic acid (Z)-, zinc salt, basic

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-10-05 to 1983-11-30

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions. Only aggregate animal data was reported.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

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

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA, USA
- Age at study initiation: not stated
- Weight at study initiation: 200 - 300 g
5 rats per cage by sex, stainless steel with elevated wire mesh flooring.
temperature - 65 - 73 degrees F, 45 - 55% humidity, 12 hr ligh/dark photoperiod. Ad libitum rodent diet & tap water.
Rats acclimated prior to dosing and fasted overnight (food only) before dosing

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50% w/v

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 per sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations - frequently on day of dosing and 2x day thereafter. Weighing - individual weights recorded on day of dosing and average group weights recorded on Days 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no mortalities during the study.

Clinical signs:

All animals appeared normal throughout the 14 -day observation period.

Body weight:

See table below.

Gross pathology:

No gross abnormalities were observed for the animals necropised at the conclusion of the study.

Other findings:

No other findings reported.

Any other information on results incl. tables

Average Body weights:

	Male (g)	Female (g)
Initial	232	211
Day 7	292	237
Day 14	334	247

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 > 5000 mg/kg. The test material is not classified in accordance with Regulation (EC) No. 1272/2008 based on studies in rats.

Executive summary:

Test Guidance

In a study similar to US EPA OPP 81 -1 the test chemical was subjected to oral toxicity testing in rats of both sexes by oral gavage dosing.

Results

All animals appeared normal throughout the 14 -day observation period. No gross abnormalities were observed for the animals necropised at the conclusion of the study. The LD50 for this study is >5000 mg/kg.

Conclusion

The test material is not classified in accordance with Regulation (EC) No. 1272/2008 based on studies in rats.