Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Remarks:
BASF AG, Experimental Toxicology and Ecology

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 520 F-Chlormethyloximether (Stufe 9 der BAS 520 FSynthese)
- Physical state: Solid, crystalline / grey
- Analytical purity: 98.3 g/100 g
- Lot/batch No.: 29388-136
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: 3.71-3.95 Kg
- Housing: single
- Diet (e.g. ad libitum): Kliba-Laboratory diet, Klingentalmuehle AG Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): About 250 ml tap water per animal per day
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 h


SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
The skin findings were reversible in all animals 72 hours after removal of the patches, thus the study was terminated.

Any other information on results incl. tables

Readings

Animal

Erythema

Edema

 

1 h

1

1

0

2

1

0

3

0

0

 

24 h

1

0

0

2

2

0

3

0

0

 

48 h

1

0

0

2

1

0

3

0

0

 

72 h

1

0

0

2

0

0

3

0

0

 

Mean

(24-72 h)

1

0.0

0.0

2

1.0

0.0

3

0.0

0.0

Mean

0.33

0.0

Under the test conditions chosen and considering the described findings, the test substance does not give indication of an irritant property to the skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU