Reaction products of “Fatty Acids, C16-18 and C18-unsatd., Me esters; sulfuric acid and sodium hydroxide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of “Fatty Acids, C16-18 and C18-unsatd., Me esters; sulfuric acid and sodium hydroxide

EC Number:

951-929-1

Molecular formula:

Not available. UVCB

IUPAC Name:

Reaction products of “Fatty Acids, C16-18 and C18-unsatd., Me esters; sulfuric acid and sodium hydroxide

Test material form:

liquid

Specific details on test material used for the study:

Batch: 2018060002
pH: 7.60
moisture content: 30.29%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Three Sprague Dawley rats (SPF Caw), supplied by Elevage JANVIER LABS (53940 Le Genest St Isle – France), were used after an acclimatisation period of at least five days. The animals were nulliparous and non-pregnant.

During the treatment, the animals were kept in individual cages. On D1, the animals were put together into their cage. The rats were kept in solid-bottomed clear polycarbonate cages with a stainless-steel mesh lid. Each cage contains dust free wood shavings which were changed at least 2 times a week.
Each cage was installed in conventional air-conditioned animal husbandry.

The temperature and relative humidity of the main test were controlled to remain within target ranges of 19°C to 25°C and 30% to 70%, respectively.

The rate of air exchange was at least ten changes cycles per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.

Drinking water (tap-water from public distribution system) and foodstuff (ENVIGO 2016) were supplied ad libitum.
Microbiological and chemical analyses of the water were carried out once every six months by Bureau Veritas – Eurofins (FRANCE).

Administration / exposure

Type of coverage:

occlusive

Details on dermal exposure:

Animals from treated group received by topical application, under non occlusive porous gauze dressing (50 mm x 50 mm non-woven swab of 4-layer patch from MEDISTOCK) secured in position with a strip of surgical adhesive tape (50 mm wides hypoallergenic microporeTM adhesive tape from 3M), an effective dose of 2 g/kg body weight administered under a volume of 2.00 mL/kg body weight during 24 hours. After 24-hour exposure period, the occlusive dressing was removed and the treated areas were rinsed with distilled water

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

other: No systemic clinical signs related to the administration of the test item were observed.

Gross pathology:

The macroscopic examination of the animals at the end of the study did not reveal treatment-related
changes.

Other findings:

Erythema was noted in all treated animals (3/3) at 24 hours post dose and was totally reversible
between Days 6 and 7. This reaction was associated with oedema in all treated animals (3/3) at
24 hours post-dose and was totally reversible on Day 6.
Dryness of the skin was noted in all treated animals (3/3) between Days 3 and 9.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in the rat.
The test item does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No signal word or hazard statement is required.

Executive summary:

The test item was applied, as supplied, onto the intact skin of 3 females Sprague Dawley rats at the dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the method as defined in the O.E.C.D. Test Guideline No. 402 dated October 9th, 2017.

No mortality occurred during the study.

No systemic clinical signs related to the administration of the test item were observed. Erythema was noted in all treated animals (3/3) at 24 hours post dose and was totally reversible between Days 6 and 7. This reaction was associated with oedema in all treated animals (3/3) at 24 hours post-dose and was totally reversible on Day 6. Dryness of the skin was noted in all treated animals (3/3) between Days 3 and 9. The body weight evolution of the animals remained normal throughout the study.

The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in the rat. The test item does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures. No signal word or hazard statement is required.