Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From October 03, 1989 to October 10, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
L-Glutamic acid, N-coco acyl derivs., monosodium salts
EC Number:
269-087-2
EC Name:
L-Glutamic acid, N-coco acyl derivs., monosodium salts
Cas Number:
68187-32-6
IUPAC Name:
L-glutamic acid, N-coco-acyl derivs., monosodium salts
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Test animals
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.32 - 2.68 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

Environmental conditions
- Temperature (°C): 15-20
- Humidity (%): 47-60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped free of fur
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
1 h, 24 h, 48 h, 72 h
Number of animals:
3
Details on study design:
Test site
- Area of exposure: dorsal/flank area
- Type of wrap if used: elasticated corset (TUBIGRIP)

Removal of the test substance
- Washing (if done): removing by gentle swabbing with cotton wool soaked in diethyl ether
- Time after start of exposure: 4h

Scoring system: Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics":

Erythema and Eschar Formation
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well-defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth)

Oedema Formation
0 No oedema
1 Very slight oedema (barely perceptible)
2 Slight oedema (edges of area well-defined by definite raising)
3 Moderate oedema (raised approximately 1 millimetre)
4 Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure)
Primary Irritation Index
0 Non-irritant
> 0 - 2 Mild irritant
> 2 - 5 Moderate irritant
> 5 - 8 Severe irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
8
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Under the study conditions, the substance was not irritating to rabbit skin.
Executive summary:

A study was conducted to determine the in vivo skin irritation / corrosion potential of the substance according to OECD Guideline 404, in compliance with GLP. New-Zealand White rabbits were exposed to 0.5 mL of undiluted test substance for 4 h. The experiment consisted of a semiocclusive coverage on clipped skin free of fur. Following application, animals were observed after 1, 24, 48 and 72 h. The mean scores for erythema and oedema were between 0.7 and 1.0 and all effects were reversible within 7 d. Under the study conditions, the substance was not irritating to rabbit skin (Safepharm Laboratories Limited, 1989).