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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-04-16-2014-05-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP in accordance with recognised guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Physical state: solid
- Analytical purity: 100%
- Expiration date of the lot/batch: not supplied (retest after 2 years)
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 200 g minimum
- Fasting period before study: None
- Housing: Animals were housed in suspended solid floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24 h exposure period and in groups of five, by sex, for the remainder of the study.
- Diet: Food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70 %
- Air changes: 15 air changes/hour
- Photoperiod: 12 h dark / 12 h light :

IN-LIFE DATES: From: To: 16/04/2014-30/04/2014

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

TEST SITE
- Area of exposure: Back and flanks
- % coverage: ca. 10% of the total body surface area
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi occluded with a piece of self adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Cotton wool moistened with arachis oil BP to remove any residual test item.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw (weighed out according to each animal's individual body weight and moistened with arachis oil prior to application.

Duration of exposure:

24 h

Doses:

Single dose level of 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 h after dosing and subsequently once daily for 14 days.
- Frequency of weighing: Individual body weights were recorded prior to application of the test item on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: Yes, at the end of the study the animals were killed by cervical dislocation and subjected to gross necropsy consisting of an external examination and opening of the abdominal and thoracic cavities.

Statistics:

Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test item was made.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed

Mortality:

No mortality was observed.

Clinical signs:

No signs of systemic toxicity were noted during the observation period.
There were no signs of dermal irritation.

Body weight:

One female showed no gain in body weight during the first week with expected gain in body weight during the second week. One other female showed an expected gain in body weight during the first week but weight loss during the second week. The remaining animals showed expected gains in body weight over the study period (please see attached table).

Gross pathology:

Patchy pallor of the liver, which may ahve been due to the time interval between termination and necropsy and not test item related, was noted at necropsy of all animals. Hydronephrosis and a cavity in the right kidney, both considered to be a genetic defect and not test item related, were also noted at necropsy of one female (please see attached table).

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the acute dermal LD50 is higher than 2000 mg/kg bw in rats therefore the substance is not classified according to CLP Regulation (EC) No. 1272/2008.

Executive summary:

Test Guidance

OECD Guideline 402 and EU Method B.3 (Acute Toxicity (Dermal).

Method and materials

A group of Wistar (RccHan^TM:WIST) rats (5/sex/dose) were given a single dermal application of test item at 2000 mg/kg bw. The test item was moistened with Arachis oil BP and placed directly on back and flanks of the skin representing approximately 10 % of the total body surface of the animals. The test site was then covered by a semi-occlusive dressing for 24 h. Animals were then observed for mortality, clinical signs and bodyweights for 14 days.

Results

No mortality and no clinical signs were observed during the study. There were no signs of dermal irritation. One female showed no gain in body weight during the first week with expected gain in body weight during the second week. One other female showed an expected gain in body weight during the first week but weight loss during the second week. The remaining animals showed expected gains in body weight over the study period. Patchy pallor of the liver, which may have been due to the time interval between termination and necropsy and not test item related, was noted at necropsy of all animals. Hydronephrosis and a cavity in the right kidney, both considered to be a genetic defect and not test item related, were also noted at necropsy of one female. The combined dermal LD50 was considered to be higher than 2000 mg/kg bw in rats.

Conclusion

Under the test conditions, the acute dermal LD50 is higher than 2000 mg/kg bw in rats therefore the test item is not classified according to CLP Regulation (EC) No. 1272/2008.