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

Endpoint summary

Description of key information

- Acute oral toxicity: LD50 (rat) = 31300 mg/kg bw
- Acute dermal toxicity: LD50 (rat) > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1963

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted prior to the implementation of current testing guideline and GLP; nevertheless, the test conduct in principle was similar to the OECD TG 401 and thus, acceptable. The study was performed on an analogue substance (for justification of read-across, please refer to the corresponding assessment report in Section 13).

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

Form: aqueous solution
The study was performed on a commercial product (aqueous solution) as the test item is manufactured and used in a liquid form.

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not specified
- Weight at study initiation: approx. 130 g
- Fasting period before study: 16 hours (food withdraw)
- Housing: individually in stock cages
- Diet: Standard laboratory rat diet (Rockland Rat Diet, Rockland Farms, New City, New York), ad libitum
- Water: ad libitum
- Acclimation period: 5 days

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

15400, 23100, 34600 and 51900 mg/kg bw (calculated doses of the undiluted test material)

No. of animals per sex per dose:

2/sex/group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: particular attention was given to observation for mortalities and clinical symptoms during the first 4 hours following treatment.
- Necropsy of survivors performed: not specified

Statistics:

The LD50 was calculated using the techniques of Weil CS (Tables for convenient calculation of median-effective dose (LD50 or ED50) and instructions in their use. Biometrics 8: 249-263, 1952), Thompson WR (Use of moving averages and interpolation to estimate median-effective dose. Bact Rev Nov 1947), and Thompson & Weil (On the construction of tables for moving average interpolation. Biometrics, March 1952).

Sex:

male/female

Dose descriptor:

LD50

Effect level:

31 300 mg/kg bw

Based on:

test mat.

Mortality:

100% (4/4) mortality was observed at 51900 mg/kg bw
50% (2/4) mortality was observed at 34600 mg/kg bw
25% (1/4) mortality was observed at 23100 mg/kg bw
no mortality occurred at 15400 mg/kg bw.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Executive summary:

For assessment of the acute oral toxicity, sodium lauriminodipropionate as a 10% active ingredient solution in water, was administered by single gavage to rats, at dose levels of 15400, 23100, 34600 and 51900 mg/kg bw. Each test group comprised 2 male and 2 female animals, observed for 14 days. The testing method in principle was similar to the OECD TG 401.

The following results were obtained:

- 100% (4/4) mortality was observed at 51900 mg/kg bw;

- 50% (2/4) mortality was observed at 34600 mg/kg bw;

- 25% (1/4) mortality was observed at 23100 mg/kg bw;

- No mortality occurred at 15400 mg/kg bw.

The LD50 was therefore calculated to be 31300 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

31 300 mg/kg bw

Quality of whole database:

Two acute oral studies in different rodent species, rats and mice, were available with good reliability (Klimisch 2). The tests were performed similarly to the corresponding OECD test guidelines with acceptable restrictions.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

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

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).

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

Specific details on test material used for the study:

solid: particulate/powder migrated information: powder

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

Two acute dermal studies in different species, rats and rabbits, were available with good reliability (Klimisch 2). The tests were performed similarly to the corresponding OECD test guidelines with acceptable restrictions.

Additional information

For oral and dermal acute toxicity, studies were available in distinct animal species. The rat studies were selected as key studies. The studies in other animal species were used as supportive. The results were consistent between all species tested.

Justification for selection of acute toxicity – oral endpoint
Rat is the preferred animal species for this type of tests.

Justification for selection of acute toxicity – dermal endpoint
Rat is the preferred animal species for this type of tests.

Justification for classification or non-classification

- Acute oral toxicity:

Based on the LD50 value in rats, the substance is not classified for acute oral toxicity according to the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC criteria.

- Acute dermal toxicity:

Based on the discrimanting dose in rats, the substance is not classified for acute dermal toxicity according to the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC criteria.

- Acute inhalation toxicity:

No classification for acute inhalation toxicity is proposed based on lack of data (no further information required).