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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From May 17, 1984 to June 5, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TK 13110 (CG 21-1201)
- Physical state: Solid
- Lot/batch No.: EP 1
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature
- Purity: Pilot sample

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 to 14 weeks
- Weight at study initiation: 2010 to 2050 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: May 17, 1984 To: May 24, 1984

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
The substance was water moistened before application.
Duration of treatment / exposure:
4 hours
Observation period:
Observations recorded after 1, 24, 48, and 72 hours after removal of the dressings
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: On the back
- % coverage: not reported
- Type of wrap if used: A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape (ISOPLAST AG, CH-5200 Brugg).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Scoring system used to evaluate the dermal reactions is the same as the system provided in the OECD guideline 404 (2002).

Symptoms - daily a.m. and p.m., once daily on weekends and holidays
Body weight - at beginning of acclimatization and end of test
Mortality - daily a.m. and p.m., once daily on weekends and holidays

Interpretation of the primary irritation index:
INDEX - CLASSIFICATION
< 0.5 non irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 irritant
5.1 - 8.0 severely irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hour
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hour
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hour
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1, 24, 48, and 72 hour
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1, 24, 48, and 72 hour
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1, 24, 48, and 72 hour
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight erythema was observed in all 3 test animals at 1 hour and these effects were fully reversible within 24 hours. No evidence of edema formation was observed in any of the test animals up to an observation period of 3 days.
Other effects:
The animals showed a normal body weight development.

Any other information on results incl. tables

The calculated primary irritation index was 0.25.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was found to be not irritant to the skin under the test conditions.