Alanine, N,N-bis(carboxymethyl)-, sodium salt (1:3)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Reference 2

Reference Type:

other: amendment

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3043/V9Z

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Animal species: rabbit / White New Zealand (SPF)
Animal supplier: dr. K. Thomae GmbH, Biberach, Germany
Age of the animals: young adult animals
Animal identification: ear tattoo
Room temperature/ Relative humidity: the animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 -24 degrees Celsius for temperature and of 30 -70 % for relative humidity. There were no deviations from these ranges which influenced the results of the study.
Day/night rhythm: 12 h/12 h (6.00 a.m. - 6.00 p.m./6.00 p.m. - 6.00 a.m.)
Type of cage: stainless steel wire mesh cages with grating,
No. of animals per cage: single housing
Bedding: no bedding in the cages; sawdust in the waste trays
Drinking water: about 250 ml tap water per animal per day
Diet: Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day).

Analysis of drinking water:
The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the Technical Services of BASF AG as well as for the presence of germs by a contract laboratory.

Analysis of feed:
The feed used in tue study was assayed for chemical and microbiological contaminants.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: undiluted, but test patch was moistened with aqua bidest.

Duration of treatment / exposure:

4 h

Observation period:

72 hours (1 animal); 15 days (2 animals)

Number of animals:

3

Details on study design:

Application site:
Upper third of the back or flanks

Number of animal(s) /animal weight(s) at the beginning of the study:
Animal: 01 / 02 / 03
Weight (kg): 3.13 / 3.28 / 3.47
Sex: male / male/ female


Observation period:
72 h animal 01
15 d animal 02 and 03

Readings:
1 h, 24 h, 48 h, 72 h, 8 d and 15 d after removal of the pach.

General observations:
A check was made twice each workday and once on Saturdays, Sundays and on public holidays for general observations and for any dead or moribund animals.


TEST SITE
- Area of exposure: clipped dorsal area ofthe trunk, 2.5 cm x 2.5 cm
- Type of wrap if used: semioccluive

REMOVAL OF TEST SUBSTANCE
- Washing: yes, washing with Lutrol and Lutrol:water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM:
OECD Draize Schema (nach Grundler, 1983)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 15 d

Remarks on result:

other: mechanical skin lesions due to adhesive test substance

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48 h

Score:

1.7

Max. score:

4

Reversibility:

not fully reversible within: 15 d

Remarks on result:

other: mechanical skin lesions due to adhesive test substance

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Readings	Animal	Erythema	Edema	Symptoms
1 hour	1	0	0
	2	0	0	MSL
	3	3	1	MSL
24 hours	1	0	0
	2	2	0	MSL
	3	2	0	MSL
48 hours	1	0	0
	2	1	0	MSL
	3	2	0	MSL
72 hours	1	0	0	Study discontinued because the animal was free of symptoms
	2	1	0	MSL
	3	1	0	MSL
8 days	2	1	0	MSL
	3	1	0	MSL
15 days	2	0	0
	3	1	0	MSL
MEAN	1	0.0	0.0
	2	1.3	0.0
	3	1.7	0.0
MEAN	1 -3	1.0	0.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met