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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
other: Conducted at GLP-accredited facility to current guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: an accredited supplier, but otherwise not stated
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): Certified Rabbit Diet, ad libitum
- Water (e.g. ad libitum): mains tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 7 March 2007 To: 14 March 2007

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
observations made 1, 24, 48 and 72 hours, and 7 days after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 0.5 ml applied under 2.5cm x 2.5cm cotton gauze patch
- Type of wrap if used: cotton gauze, surgical tape, elasticated corset


REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton woll soaked in distilled water
- Time after start of exposure: 4 hours


SCORING SYSTEM: eryhtema/eshar - 0-4, oedema - 0-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
65962 male
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
65962 male
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 48h
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
65962 male
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
65962 male
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 24h
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
65961 male
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
65961 male
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48h
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
65961 male
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
65961 male
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 24h
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
65960 male
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
65960 male
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
65962 male
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
65962 male
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
65962 male
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
65962 male
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 24h
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
65961 male
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
65961 male
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
probability of mild irritation
Remarks:
Loss of skin elasticity
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
65961 male
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
65961 male
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 24h
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
65960 male
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
other: animal showed slight desquamation
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
65960 male
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
65960 male
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
65960 male
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 24h
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
65960 male
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 24h
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
65960 male
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 48h
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of mild irritation

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Not classified for skin irritation according to EU DSD/DPD or CLP criteria.