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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate
EC Number:
250-151-3
EC Name:
Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate
Cas Number:
30364-51-3
Molecular formula:
C17H32NO3.Na
IUPAC Name:
sodium [methyl(tetradecanoyl)amino]acetate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Sodium myristoyl sarcosinate
- Physical state: white powder
- Analytical purity: 90-95%
- Arrival date: 24 September 2012
- Lot/batch No.: 537804
- Expiration date of the lot/batch: 24 September 2014
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
other: RCCHan:WIST
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
- Weight at study initiation: 240-370 g (males) and 207-228 g (females)
- Housing: animals were housed individually during the exposure period and in groups of up to four, by sex, for the remainder of the study.
- Diet: 2014C Teklad Global Rodent diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: arachis oil BP
Details on dermal exposure:
TEST SITE
- Area of exposure: backs and flanks
- % coverage: approximately 10%
- 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: the treated skin and surrounding hair were wiped with cotton wool moistened with arachis oil BP to remove any residual test item.
- Time after start of exposure: 24 h


Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for clinical signs at 30 min, 1, 2 and 4 h after dosing and subsequently once daily for 14 days. Individual body weights were determined on Day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, evaluation of dermal reactions using the Draize scoring system.

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 occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
The test animals showed expected body weight gains during the study period with the exception of one female which showed bodyweight loss during the first week but expected weight gain during the second week.
Gross pathology:
Necropsy revealed no substance-related findings.
Other findings:
- Other observations: very slight erythema (Draize scoring value: 1) was noted at the test sites of 7/10 animals being fully reversible within 5 days. No edema formation was observed in any animal. Crust formation was also noted at the test site of one female being reversible within 9 days. There were no signs of dermal irritation noted at the test sites of the remaining animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified

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