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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
05 January 2001 to 18 July 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted in accordance with International Guidelines and in accordance with the principles of Good Laboratory Practise (GLP).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

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
Details on test material:
- Name of test material (as cited in study report): EH&S 01-114
- Lot/batch No.:XC1B1263A0

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gingrich Animal Supply, Inc, Fredericksburg, PA, USA
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 2.5 - 2.7 kg
- Housing: One per cage in suspeneded wire cages. Bedding was placed beneath the cages and changed at least 3 times a week.
- Diet (e.g. ad libitum): Fresh Purina rabbit chow (diet n.o 5321) was provided daily
- Water (e.g. ad libitum): Water was freely available at all times
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
The animal room was reserved exclusively for rabbits on acute tests, temperature was controlled, had a 12 hour light / dark cycle and was kept clean and vermin free.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Clipped free of hair
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: The prepared clipped area was 10 x 10 cm
- Type of wrap if used: The test article was placed under a 2.5 x 2.5 cm, 4 ply surgical gauze patch. The patch was secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape which completely covered the plastic.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period and prior to scoring the residual test material was removed from the test site by gentle washing with distilled water.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
The test sites were scored for dermal irritation at 60 minutes following patch removel. Reactions were scored again at 24, 48 and 72 hours post dose. Erythema and edema were scored according to the Draize technique below. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
Animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
Animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
Animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
Animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Dermal observations:
There was no erythema or edema noted at any time period.
Other effects:
Systemic observations and bodyweight:
There were no abnormal physical signs noted.
All bodyweight changes were normal.

Any other information on results incl. tables

The test substance is not a dermal irritant.

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 a dermal irritant.
Executive summary:

The study was performed to determine the irritant or corrosive effects of the test substance when applied dermally. The study was carried out based on the OECD Guideline no. 404 "Acute Dermal Irritation /Corrosion"

Method

Since the test article was not expected to produce severe irritation or corrosion, three healthy New Zealand White rabbits (males) were dosed dermally with the test substance. The test substance (0.5 ml) was applied dermally to one intact site/rabbit. The test substance was kept in contact with the skin for 4 hours at which time the wrappings were removed. Dermal reactions were scored at 60 minutes following patch removal. Reactions were scored again at 24, 48 and 72 hours following patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Body weights were recorded pretest and at at termination.

Summary:

There was no erythema and edema noted at any observation time period.

There were no abnormal physical signs noted during the observation period.

All body weight changes were normal.

Conclusion:

The test substance is not a dermal irritant.