Amines, C12-18-alkyl, reaction products with acrylic acid, sodium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This OECD guideline and GLP-compliant study was performed on an analogue substance (for justification of read-across, please refer to the corresponding assessment report in Section 13).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate

EC Number:

239-032-7

EC Name:

Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate

Cas Number:

14960-06-6

IUPAC Name:

Sodium Lauriminodipropionate

Test material form:

other: liquid

Details on test material:

- Common name : Sodium lauriminodipropionate
- For more details, see below the Confidential details for test material

Specific details on test material used for the study:

solid: particulate/powder migrated information: powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation:203-236g
- Housing:Makrolon cage, type III
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:Acclimatization period of at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22°C +- 3°C
- Humidity (%):30 – 70%
- Air changes (per hr):10
- Photoperiod (hrs dark / hrs light):12 h / 12 h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

olive oil

Details on dermal exposure:

TEST SITE
- Area of exposure:40 cm²
- % coverage: at least 10% of the body surface
- Type of wrap if used:semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: suspension in Olive Oil

VEHICLE (olive oil)
- Amount(s) applied (volume or weight with unit): 20 mL/kg bw (substance in vehicle)
- Concentration (if solution): 25 g/100 mL (concentration of substance in olive oil)

Duration of exposure:

24 hours

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Clinical observations: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Scoring of skin findings: Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1) and several times (see results) until the last day of observation
- Mortality: A check for any dead or moribund animals was made at least once each workday
- Pathology: Necropsy with gross-pathology examination on the last day of the observation period

Statistics:

Common statistical procedures

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred

Clinical signs:

other: No systemic clinical signs were observed during clinical examination

Gross pathology:

No macroscopic abnormalities were observed

Other findings:

Skin effects at the application site comprised very slight erythema (grade 1) in all male animals and were observed on study day 1 and 2.

Skin effects at the application site comprised very slight erythema (grade 1) in four out of five female animals on study day 1 until day 2. One animal revealed very slight erythema on study day 1, well-defined erythema (grade 2) on study day 2 and again very slight erythema on day 3; additionally very slight edema (grade 1) was noted in this animal on day 2 and scaling on day 6. Scaling was also noted in two other animals on day 6; one of these animals also revealed incrustations on day 6.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: EU GHS (CLP)

Conclusions:

Under the conditions of this study the median lethal dose (LD50) of the test item after dermal application was found to be higher than 5000 mg/kg bw in male and female rats.

Executive summary:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females)were dermally exposed to a single dose of 5000 mg/kg bw of sodium lauriminodipropionate (as a suspension in olive oil) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours according to the OECD 402 test guideline. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.

 

The following test item-related local effects were recorded during the course of the study: very slight to well-defined erythema (grade 1 to 2), very slight edema (grade 1), incrustations and scaling.

The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weight of the female animals did not significantly change during the first post-exposure observation week. This difference is commonly observed in the rat strain used, because in the required age range the female animals have already reached the phase of slow growth.

No signs of systemic toxicity or mortality were observed in the animals. No macroscopic pathologic abnormalities were noted in the animals upon necropsy.

 

Accordingly, the acute dermal median lethal dose (LD₅₀) was determined to be higher than 5000 mg/kg bw.