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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye 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 405 (Acute Eye 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 F Synthese)
- 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 / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: 2.19-2.45 Kg
- Housing: single
- Diet: Kliba-Laboratory diet, Klingentalmuehle AG Kaiseraugst, Switzerland (about 130 g per animal per day), ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 1 week


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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (about 43 mg)
Duration of treatment / exposure:
24 h
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with tap water
- Time after start of exposure: 24


SCORING SYSTEM: according to OECD guideline 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24- 48- 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The average score (24 to 72 hours) for irritation was calculated to be 1.0 for corneal opacity, 0.7 for iris, 2.9 for conjunctival redness and 2.1 for chemosis (Table 1). The findings were reversible in all animals within 21 days after application; thus the study was terminated.

Any other information on results incl. tables

Table 1: Irritation scores

Readings

Animal

Cornea

Iris

Conjunctivae

Chemosis

Symptoms

 

1 h

1

0

0

2

2

 

2

0

0

2

1

 

3

0

1

1

3

 

 

24 h

1

1

1

3

3

S, DB

2

1

1

3

2

S, DB

3

1

1

2

3

S, DB

 

48 h

1

1

1

3

2

S, PC, DB

2

1

1

3

1

S, DB

3

1

1

3

3

S, DB

 

72 h

1

1

0

3

2

S, PC, DB

2

1

0

3

1

DB

3

1

0

3

2

S, DB

 

7 days

1

0

0

1

0

 

2

0

0

2

0

 

3

0

0

2

0

 

 

14 days

1

0

0

1

0

 

2

0

0

1

0

 

3

0

0

1

0

 

 

21 days

1

0

0

0

0

 

2

0

0

0

0

 

3

0

0

0

0

 

 

Mean

(24-72 h)

1

1.0

0.7

3.0

2.3

 

2

1.0

0.7

3.0

1.3

 

3

1.0

0.7

2.7

2.7

 

Mean

1.0

0.7

2.9

2.1

 

Under the test conditions chosen and considering the described findings, the test substance gives indication of an irritant property to the eye.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU