Ammonium N-methyl-N-(1-oxododecyl)glycinate

Endpoint summary

Description of key information

Skin irritation (OECD 404), rabbit: not irritating
Eye irritation (OECD 405), rabbit: severe eye damage

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-10-25 to 2004-11-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2002

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: 4166310

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature

Species:

rabbit

Strain:

other: Albino rabbits (Chbb:HM)

Details on test animals or test system and environmental conditions:

TEST animals:
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Weight of study initiation: 2500 - 2600 g
- Housing: the rabbits (females) were caged individually in polyphenyl ether (PPE) cages with perforated floor.
- Diet: pelleted complete diet Altromin 2123 (Altromin GmbH, Lage, Germany), ad libitum
- Water: (tap/filtered) water acidified with hydrochloric acid, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark/hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

other: untreated site of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h

Observation period:

Initial test: 7 days
Reading time points: 1, 24, 48 and 72 h and 7 days

Confirmatory test: 14 days
Reading time points: 1, 24, 48 and 72 h and 7 and 14 days

Number of animals:

initial test: 1 female
confirmatory test: 2 females

Details on study design:

TEST SIDE:
- Area of exposure: 6,25 cm² on the right side of the back
- Type of wrap: The treated skin was covered with adhesive Gothaplast tape (2,5 cm)

REMOVAL OF TEST SUBSTANCE:
- Washing: Residual test material was removed with mild soap and lukewarm water.
- Time after start of exposure: initial test: 3 min, 1 and 4 h: confirmatory test: 4 h

SCORING SYSTEM:
Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

other: mean of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

- Animal #1 showed a well-defined erythema on the posterior right test field immediately after the application.
- 1 h after termination of exposure a well-defined erythema was observed on the posterior right test field of animal #1. Animal #2 and #3 showed a very slight erythema on the anterior left test fields.
-24 h, 48 h and 72 h after the termination of exposure a well-defined erythema was observed on the posterior right test field of animal #1. Animals #2 and #3 showed a well-defined erythema on the anterior left test field.
- 7 days after the termination of the exposure isolated scales were still observed on the anterior left test field of animal #2 and #3. Animal #1 showed no skin reactions.
- 14 days after the termination of exposure animals #2 and #3 were free of any signs of skin irritation, too.

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 (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2004-11-08 to 2004-11-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: 4166310

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature

Species:

rabbit

Strain:

other: Albino rabbit (Chbb:HM)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS:
- Source: DIMED Schönwalde GmbH, Schönwalde, Germany
- Age at study initiation: 104 weeks
- Weight at study initiation: 2700 g
- Housing: individual female rabbit was caged in a polyphenyl ether (PPE) cage
- Diet: pelleted complete diet Altromin 2123 (Altromin GmbH, Lage, Germany), ad libitum
- Water: (tap/filtered) water acidified with hydrochloric acid, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

water

Controls:

other: The untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

1 h

Observation period (in vivo):

21 days
Reading time points: 1, 24, 48 and 72 h and 7, 14 and 21 days

Number of animals or in vitro replicates:

1 female

Details on study design:

REMOVAL OF TEST SUBSTANCE:
- Washing: The treated eye was rinsed with 40 mL 0.9% saline solution
- Time after start of exposure: 1 h

SCORING SYSTEM:
- Draize scoring system

TOOL USED TO ASSESS SCORE:
- fluorescein

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 1 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 1 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

other: eye has been washed 1 h p.a. due to severe immediate effects

Irritant / corrosive response data:

- The treated eye showed severe irritating/corrosive effects already 1 h after treatment with the test item. Therefore, the test item was washed out with 40 mL of 0.9% saline solution.
- Cornea, iris, conjunctivae and chemosis score were determined 1, 24, 48 and 72 h and 7, 14 and 21 days after removal of the test item.
- the eye irritating/corrosive effects were fully reversible within 21 days

Table 1: Summary of eye irritation scores

Animal-No./weight in kg	Irritation parameter	1 h	24 h	48 h	72 h	Mean	7 days	14 days	21 days
1 / 2,7	Cornea score (degree)   Cornea score (area)	3       4	2       4	2       4	2       4	2       4	1       3	0       0	0       0
	Iris score	2	1	1	1	1	1	0	0
	Conjunctivae score	3	2	2	2	2	1	1	0
	Chemosis score	3	3	1	1	1,67	0	0	0

Remark: Only time points 24, 48 and 72 h were used for calculation of mean value.

Interpretation of results:

other: Eye damage 1, H318. Classification according to Regulation (EC) No. 1272/2008 (CLP/EU GHS).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In the reliable skin irritation study performed according to OECD TG 404 and in compliance with GLP three female SPF albino rabbits were exposed to 0.5 mL Ammonium lauroyl sarcosinate (CAS 68003-46-3) onto the clipped skin for 3 min, 1 and 4 h under semi-occlusive coverage (Frey-Tox, 2004b). Skin reactions were evaluated according to the Draize scoring system 1, 24, 48 and 72 h and 7 days post-application. No symptoms of systemic toxicity were observed in any animal during the test period and no mortality occurred during the course of the study. All tested animals showed well-defined erythema (grade 2) 24 to 72 hours post-administration. Edema formation was not observed during the study period. All skin reactions were fully reversible within the 14-day observation period. Based on the study results and according to EU classification criteria, the test substance is not considered to be irritating to the skin.

 

Eye irritation

In the reliable eye irritation study with Ammonium lauroyl sarcosinate (CAS 68003-46-3) performed according to OECD TG 405 (Frey-Tox, 2004c) 0.1 mL of the test substance was instilled in the eye of one female Albino rabbit. The exposure period was 1 h, only, due to severe reactions of the animal. The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours and 7, 14 and up to 21 days post application. Within 24 to 72 hours post-application mean values of corneal opacity (grade 1.33), redness (grade 2), chemosis (grade 1.67) and light sensitivity of the iris (grade 1) were calculated. All observed effects were fully reversible within 21 days. In spite of the irritant and corrosive effects 1 h post administration no further experiments on additional animals were performed. Based on the study results and according to EU classification criteria, the test substance is considered to cause severe damages to the eye.

Justification for classification or non-classification

The available data on skin irritation / corrosion of Ammonium N-methyl-N-(1-oxododecyl)glycinate (CAS 68003-46-3) do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP). The available data on eye irritation, however, meet the criteria for classification for Eye Damage 1 (H318) according to Regulation (EC) No. 1272/2008 (CLP).