β-Alanine, N-coco alkyl derivs.

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:

other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Justification for type of information:

Β-Alanine, N-coco alkyl derivatives (cas: 84812-94-2, EINECS: 284-219-9) is an alkylamine carboxylate made by reacting cocoamine with acrylic acid to form monoproprionate and diproprionate acids. This UVCB substance contains a diverse range of both mono and di-propionates.
The family of propionates have very similar properties and functions. There is no specific acute dermal toxicity data for this substance but the subsrance referred to here is assessed to be structurally and toxicologically similar.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nohsan, Notification No 8147, April 2011; including the most recent partial revisions.

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

305-318-6

EC Name:

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

Cas Number:

94441-92-6

Molecular formula:

C14H26NO4.Na

IUPAC Name:

sodium 3-[(2-carboxyethyl)(2-ethylhexyl)amino]propanoate

Test material form:

other: Clear amber liquid

Details on test material:

- Name of test material (as cited in study report): Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-ß-alaninate
- Substance type: Clear amber liquid
- Physical state: liquid
- Composition:
59.6 Weight % Water
40.4 Weight% Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-ß-alaninate
- Lot/batch No.: S-001084
- Expiration date of the lot/batch: 09 January 2018
- Storage condition of test material: At room temperature in the dark
- Volatile: No
- Density: 1.081 kg/m3 at 20°C
- pH: 8.5-9.5 at 20% solution

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 10 weeks old)
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean (males: 271 grams; females: 186 grams).
- Housing: Individual housing in labeled Macrolon cages
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle.

IN-LIFE DATES: From: 02 - 16 May 2012

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

One day before exposure (Day -1) an area of approximately 5x7 cm on the back of the animal was clipped.

The test substance was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D)*, successively covered with aluminum foil and Coban elastic bandage*. A piece of Micropore tape* was additionally used for fixation of the bandages in females only. *. Manufacturers: Laboratoires Stella s.a., Liege, Belgium (surgical gauze) and 3M, St. Paul, Minnesota, U.S.A. (Coban & Micropore).

Frequency: Single dosage, on Day 1.

Washing: Following application, dressings were removed and the skin cleaned of residual test substance using tap water.

Duration of exposure:

24 hours.

Doses:

2000 mg/kg (4.63 mL/kg) body weight. Dose levels were corrected for a purity of 40%.

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Dose volume: 4.63 mL/kg

Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily.
Body weights: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.
- Other examinations performed: none.

Statistics:

None.

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.

Clinical signs:

Hunched posture and/or chromodacryrrhoea were noted in all animals on Day 1 and/or 2. In addition, one female and one male showed piloerection on Day 1. No skin effects were noted on the treated skin during the observation period.

Body weight:

The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.

Gross pathology:

One female showed smaller spleen compared to normal. No further abnormalities were found at macroscopic post mortem examination of the animals.

Other findings:

none

Applicant's summary and conclusion

Conclusions:

The dermal LD50 value of Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-ß-alaninate in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results, Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-ß-alaninate does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the:
- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011),
- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.