Reaction mass of stearoyl sarcosine and palmitoyl sarcosine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

16 Jun 2013 to 15 Jan 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 24 February, 1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Groupe Interministeriel des Produits Chimique, Fait a Ivry, France, 13 Sep 2013

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-lauroylsarcosine

EC Number:

202-608-3

EC Name:

N-lauroylsarcosine

Cas Number:

97-78-9

Molecular formula:

C15H29NO3

IUPAC Name:

N-dodecanoyl-N-methylglycine

Test material form:

other: waxy solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Janvier, Le Genest St Isle, France
- Age at study initiation: 7 weeks (males), 8 weeks (females)
- Weight at study initiation: 232-252 g (males), 207-224 g (females)
- Housing: Individually during treatment, then in groups of five from day 1 on in solid- bottomed clear polycarbonate cages with a stainless steel mesh lid. Dust free sawdust was used as bedding, changed at least twice per week
- Diet: SAFE - A04, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 13
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 30 Jul 2013 To: 13 Aug 2013

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10%
- Type of wrap if used: porous gauze dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated areas were rinsed with distilled water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.14 mL/kg bw (corresponding to 2 g/kg, according to the calculated density)

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: examination of behavioural or toxic effects/mortality daily, weighing was performed on D0 and then on D2, D7 and D14.
- Necropsy of survivors performed: yes, on D14
- Other examinations performed: clinical signs, body weight, organs likely to be modified in cases of acute toxicity. Organs presenting macroscopic anomalies could optionally be removed and preserved for subsequent microscopic examinations.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study period.

Clinical signs:

other: No systemic clinical signs of toxicity related to the administration of the test item were observed up to the end of the 14-day observation period.

Gross pathology:

Macroscopic examination at the end of the study revealed no treatment-related changes.

Other findings:

- Other observations: Cutaneous reactions (erythema, dryness and scab) were noted from Day 1 in all animals and remained until Day 14 (scab) in all females and one in one male.

Any other information on results incl. tables

Conclusion:

The dermal LD50 of the test item in the rat was higher than 2000 mg/kg/bw.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.