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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 October 1989 to 10 October 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
Chemical structure
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
Molecular formula:
C17 H32 N1 O4 Na1
IUPAC Name:
l-Glutamic acid, N-coco acyl derivs., monosodium salts

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.32 - 2.68 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 20°C
- Humidity (%): 47 - 60%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other:
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
1h, 24h, 48h, 72h
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 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
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24h, 72h,
Score:
0.5

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to EU criteria
Conclusions:
Under the conditions of the study, the test material was not irritating to the skin.
Executive summary:

The test material was investigated for its skin irritation potential in accordance with the standardised guideline OECD 404, under GLP conditions.

During the study the dorsal/flank area of three New Zealand White rabbits was clipped free of fur. 0.5 mL of test material was evenly spread over the intact sites and was held in place, under a semiocclusive dressing, with an elasticated corset. At the end of the 4 -hour exposure period the test material was removed by gentle swabbing with cotton wool soaked in diethyl ether. Test sites were observed for signs of erythema and oedema 1, 24, 48 and 72 hours following removal of the test material.

Under the conditions of the study, no signs of oedema were noted. Very slight erythema was noted in two animals but this effect was fully reversible within 7 days. The mean scores for erythema and oedema were 0.7 and 0, respectively.

Consequently the test material was not considered to be irritating to the skin.