Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1989/10/03 - 1989/10/10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The registered substance is a UVCB material which contains substances of varying chain length. Read across was performed to an analogous material whose carbon chain length differs by an average of two CH2-groups from the registered substance. Because of the UVCB nature of these substances, the components of the registered substance were also present in the test material, albeit at slightly different concentration levels.

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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)
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not irritating to the skin.
Executive summary:

The read-across from a study with an analogous substance was scientifically justified, because the analoguous substance was the disodium salt to the monosodium salt of the test substance. The chain length of the test substance differs by an average of two CH2 groups from the registered substance, but BEING AN UVCB SUBSTANCE; ALL CHEMICAL SPECIES WERE PRESENT ALSO IN THE TEST SUBSTANCE - ALTHOUGH AT SLIGHTLY DIFFERENT CONCENTRATION LEVELS.

The test substance was investigated for its skin irritation potential in accordance with OECD guideline 404 under GLP conditions. The mean scores for erythema and oedema 0.7 and 0. All effects were reversible after 7 days. Consequently the test substance is not considered to be skin irritating.