Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted study similar to guideline (GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl (2E)-2-methoxyimino-2-[2-[(2-methylphenoxy)methyl]phenyl]acetate
EC Number:
604-351-6
Cas Number:
143390-89-0
Molecular formula:
C18 H19 N O4
IUPAC Name:
methyl (2E)-2-methoxyimino-2-[2-[(2-methylphenoxy)methyl]phenyl]acetate
Details on test material:
- Name of test material (as cited in study report): Reg. No. 242 009 (test substance number: 91/180-2)
- Lot/batch No.: N 36 (= III C1); date of manufacturing: 1991-10-23
- Storage condition of test material: room temperature, exclusion of light
- Physical state: solid (powder) / light brown
- Analytical purity: 93.7% (Reversed-Phase - HPLC with UV-Detection)
- Stability under test conditions: the storage stability was guaranteed over the study period
- Other: the homogeneity of the test substance was confirmed by analysis (Reversed-Phase - HPLC with UV-Detection)

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler; D-W6050 Offenbach / Main, FRG
- Age at study initiation: young adult animals identified by Ear tattoo
- Weight at study initiation: 3.34-3.60 kg for females (4 animals) and 3.27-3.56 kg for males (2)
- Housing: singly in stainless steel cage with wire mesh walk floors; floor area: 40 cm x 51 cm
- Diet (e.g. ad libitum): KLIBA Labordiaet 341; Klingentalmuhle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): tap water (ca. 250 ml per animal per day)
- Acclimation period: at least one week

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 39 mg of the comminuted test substance)
Duration of treatment / exposure:
the substance was not washed out of the eyes
Observation period (in vivo):
because all effets were reversible within 48-72 hours, the observation period was limited to 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: according to OECD Guideline 405 (adopted Feb. 24, 1987) and EEC L 251, B.5 (Sept. 19, 1984); readings were done 1 hour, 24 hours, 48 hours and 72 hours after treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Remarks:
of all tested animals
Time point:
other: 24-48-72-hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all tested animals except animal 5
Time point:
other: 24-48-72-hour
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24-48-72-hour
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all tested animals
Time point:
other: 24-48-72-hour
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all tested animals
Time point:
other: 24-48-72-hour
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritant / corrosive response data:
All treated animals showed a conjunctiva redness (score: 1) at the 1-hour reading. At the 48-hour reading, this score was still observable in only one animal and fully reversible afterwards.

Based on the irritation scores the test substance is not irritating to the rabbit eye according to the EU and to GHS
Other effects:
no others effects were observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information