Registration Dossier

Toxicological information

Skin irritation / corrosion

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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.