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Administrative data

Description of key information

Oral: (WoE, OECD 401), rat: LD50 > 5000 mg/kg bw

RA from Sodium N-lauroylsarcosinate (CAS 137-16-6) and N-methyl-N-[C18-(unsaturated)alkanoyl]glycine (EC 701-177-3)

Inhalation: Data waiving as studies for two other routes, i.e. oral and dermal, are provided.

Dermal (OECD 402), rat (m/f): LD50 > 2000 mg/kg bw (limit test)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
Summary of available data used for the endpoint assessment of the target substance
Adequacy of study:
weight of evidence
Justification for type of information:
Please refer to analogue justification report provided in IUCLID section 13
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Source: CAS 137-16-6, Toxicol Laboratories Ltd, 1987

Additional study taken into account in a Weight-of-Evidence approach:

EC 701-177-3, Ciba Geigy, 1981a: LD50 (rat, m/f) > 5000 mg/kg bw

EC 701-177-3, BASF, 1979: LD50 (rat) = 9200 mg/kg bw

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Quality of whole database:
The available information comprises adequate and reliable (Klimisch score 2) studies from source substances with similar structure and intrinsic properties. Read-across is justified based on common functional group(s) and similar physico-chemical, ecotoxicological and toxicological properties of the source and the target substances. Taken together, the information from these independent sources is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No. 1907/2006 (REACH). Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No. 1907/2006 (REACH).

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 Oct 2012 - 14 Nov 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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
Limit test:
yes
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
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.
Key result
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.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 1) performed with the registered substance, and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, Item 8.5, of Regulation (EC) No. 1907/2006 (REACH).

Additional information

Acute toxicity: oral

No data on acute oral toxicity are available with Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364 -51-3). Therefore, following a Weight-of-Evidence approach, data available for the analogue substances Sodium N-lauroylsarcosinate (CAS 137-16-6) and N-methyl-N-[C18-(unsaturated)alkanoyl]glycine (EC 701-177-3) are considered for this endpoint.

The acute toxicity via the oral route of the analogue substance Sodium N-lauroylsarcosinate (CAS 137-16-6) was investigated in rats in a study performed according to OECD TG 401 and in compliance with GLP (Toxicol. Laboratories Ltd., 1987). Groups of 5 Sprague Dawley rats of each sex were treated with the limit dose of 5000 mg/kg bw of the test substance via oral gavage. The observation period following administration was 14 days. During the study period, one female animal died at Day 2. No clinical signs of toxicity were observed in the surviving animals. All surviving animals showed normal body weight gain. The female animal found dead had been cannibalised and autolysed. Thus, no detailed post-mortem examination was possible. In surviving animals no abnormalities were noted at necropsy. Thus, the oral LD50 value for male and female rats was considered to be greater than 5000 mg/kg bw.

Furthermore, an acute oral toxicity study performed equivalent or similar to OECD TG 401 with the analogue substance N-methyl-N-[C18-(unsaturated)alkanoyl]glycine (EC 701-177-3) is available (Ciba Geigy, 1981a). In this limit test five fasted Sprague-Dawley rats of each sex were administered a single dose of 5000 mg/kg bw of the test substance via oral gavage. The animals were observed for 14 days after administration. No mortality occurred during the study period and body weight gain was normal. Observed clinical signs included slight dyspnoea, slight exophthalmos and slight to moderate ruffled fur and slight to moderate diarrhoea as well as a slightly curved body position. All these clinical signs were fully reversible in all animals within 7 days. No substance-related findings were recorded at necropsy. Thus, the acute oral LD50 value was considered to be greater than 5000 mg/kg bw.

For this substance a further study with limited data is available which was conducted similar to OECD TG 401 (BASF, 1979). Rats were given the test material per oral administration. No further study details were provided. The authors determined the oral LD50 for rats to be greater than 9200 mg/kg bw.

Acute toxicity: inhalation

No data on acute inhalation toxicity are required as data on two other routes of exposure, i.e. oral and dermal, are provided.

Acute dermal toxicity

The acute dermal toxicity of Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3) was evaluated in rats in accordance with OECD TG 402 under GLP conditions (Harlan, 2013a). Groups of 10 rats (5 males and 5 females) were treated with the test substance moistened with arachis oil BP at the limit dose of 2000 mg/kg bw under semi-occlusive conditions for 24 h. The animals were observed for a period of 14 days following administration. During the study period, no mortality and no clinical signs of toxicity occurred in any animal. No substance-related findings during necropsy were observed in any animal. No effects on body weight gain were observed with the exception of one female which showed bodyweight loss during the first week but expected weight gain during the second week. Evaluation of the dermal skin reactions showed very slight erythema (Draize scoring value: 1) at the test sites of 7/10 animals being fully reversible within at the most 5 days. No edema formation was observed in any animal. Crust formation was noted at the test site of one female being reversible within 9 days. Thus, the dermal LD50 for male and female rats was considered to be greater than the tested limit dose 2000 mg/kg bw.

Conclusion

Taken together, the available data on oral and dermal acute toxicity obtained either with the registered substance or with adequate source substances do not indicate any relevant acute toxicity.

Justification for classification or non-classification

The available data on the registered substance and relevant read-across source substances for acute oral and acute dermal toxicity do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP). Therefore, applying the read-across approach, the registered substance Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3) is also considered not to meet the criteria for classification for acute oral and dermal toxicity. The oral and dermal toxicity data are, therefore, considered conclusive but not sufficient for classification; due to the lacking of suitable data, no assessment is possible with respect to acute inhalation toxicity.

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