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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
Data available from in-vivo studies preformed before the in-vitro requirement.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 27 Mar to 03 Apr 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study run to a reliable method and to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: US DOT Corrosive guidelines under 49 CFR:173.1200
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: not specified
Batch No.: not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: a suitably licensed dealer
- Age at study initiation: about three months
- Weight at study initiation: approximately two kilograms
- Housing: individually housed in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3 to 23.9
- Humidity (%): monitored
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 27 Mar To: 03 Apr 1990

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 centimeters square
- % coverage:
- Type of wrap if used: gauze sponge

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were gently washed with water to remove any remaining test article.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize skin scoring scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: The exposure period is 4 hours.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: The exposure period is 4 hours.

Any other information on results incl. tables

RABBIT NUMBER

SKIN

HOURS:4

 

48

 

DAY: 7

 

 

 

ER

ED

ER

ED

ER

ED

1

INTACT

2

1

2

2B

4

4C

2

INTACT

2

1

2

2B

4

4C

3

INTACT

1

1

2

2B

2

0S

4

INTACT

2

1

2

2B

4

4C

5

INTACT

2

1B

2

2B

4

4C

6

INTACT

2

1

2

2B

4

4C

 ER/ED= Erythema and Edema Scores

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
This test substance is corrosive to rabbit skin.