N-lauroylsarcosine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

21 Sep - 2 Nov 2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium N-lauroylsarcosinate

EC Number:

205-281-5

EC Name:

Sodium N-lauroylsarcosinate

Cas Number:

137-16-6

IUPAC Name:

sodium [dodecanoyl(methyl)amino]acetate

Test material form:

other: aqueous formulation

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: colourless liquid
- Analytical purity: 30%
- Impurities (identity and concentrations): conditional on production the product still contains really approx. 1-2% Natrium-laurat)
- Lot/batch No.: 4165892
- Storage condition of test material: room temperature

- Other:
pH: (10%) = 7.5 - 9.0

Test animals / tissue source

Species:

rabbit

Strain:

other: SPF albino - Littlerussian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: DIMED Schonwalde GmbH, Schonwalde
- Age at study initiation: approx. 6-7 months
- Weight at study initiation: 2.4-2.6 kg
- Housing: During a pre-period of at least one week and throughout the study the rabbits were caged individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.
- Diet: A pelleted complete rabbit diet "Altromin 2123" was available, ad libitum.
- Water: The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth, ad libitum.

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

Test system

Vehicle:

water

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): 30% (v/v)

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

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

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE:
Initial test:
The treated eye was examined and the grade of ocular reaction was recorded 1 h and 24 h later. After the 24 h-reading Fluorescein was instilled. After irrigation with 20 mL 0.9 % sodium chloride solution the eye was examined again using UV light to detect possible corneal damage. The eye was also examined 48 h and 72 h after the treatment as well as on day 7 and 14.

Confirmatory Test:
During the confirmatory test the eyes of the animals were likewise examined for ocular reactions 1 h, 24 h, 48 h and 72 h after the application as well as on Day 7, 14 and 21.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Any other information on results incl. tables

Table 1. Results of eye irritation study.

Rabbit #	Time [h]	conjunctivae		iris	cornea		conjunctivae		iris	cornea
		redness	swelling				redness	swelling
1	1 h	3	2	0	1
	24 h	2	2	1	1
	48 h	1	1	1	1
	72 h	1	1	1	1
	average	1.3	1.3	1.0	1.0	Time to reversion	14	7	7	14
2	1 h	2	1	1	1
	24 h	2	2	1	2
	48 h	2	1	1	1
	72 h	2	1	1	1
	average	2.0	1.3	1.0	1.0	Time to reversion	14	7	7	21
3	1 h	2	1	0	1
	24 h	2	2	1	1
	48 h	2	2	1	1
	72 h	2	1	1	1
	average	2.0	1.7	1.0	1.0	Time to reversion	14	7	7	7
	Time [h]	conjunctivae		iris	cornea
		redness	swelling			avg. time to reversion [Days]	14	7	7	14
average score	1	2.33	1.33	0.33	1.00
	24	2.00	2.00	1.00	1.33
	48	1.67	1.33	1.00	1.00
	72	1.67	1.00	1.00	1.00
	24+48+72	1.78	1.44	1.00	1.00

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: Eye irrit 2, H319
DSD: Xi, R36

Executive summary: