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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted May 12th, 1981
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutyl (S)-2-chloropropionate
EC Number:
280-349-5
EC Name:
Isobutyl (S)-2-chloropropionate
Cas Number:
83261-15-8
Molecular formula:
C7H13ClO2
IUPAC Name:
isobutyl (S)-2-chloropropanoate
Details on test material:
- Name of test material (as cited in study report): L-Chloropropionic acid isobutyl ester
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: June 1985
No further data.

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
female Vienna white rabbits
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: no data
- Weight at study initiation: 2.86, 3.09, 2.69 kg (animal no. 1, 2, 3, respectively)
- Housing: single housing in steel cages with wire mesh bottom (ground area: 40 cm x 51 cm)
- Diet: Ovator Solikanin 4mm (Muskator Werke, Düsseldorf), ca. 130 mg/day
- Water: tap water, ca. 250 ml/day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the test animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
single application without rinsing
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
Draize scale in accordance with OECD; readings at 1 h, 24 h, 48 h, 72 h, and 8 d after instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: see table for details
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 h
Score:
1.11
Max. score:
3
Reversibility:
fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

reading animal cornea iris conjunctivae irritation score
    opacity area   redness swelling secretion individual mean
1 h 1 0 0 0 2 1 1 8 9
2 0 0 0 2 1 1 8
3 0 0 0 2 2 2 12
24 h 1 0 0 0 1 0 1 4 7
2 0 0 0 2 1 1 4
3 0 0 0 2 1 1 8
48 h 1 0 0 0 0 0 0 0 2
2 0 0 0 1 0 0 2
3 0 0 0 2 0 0 4
72 h 1 0 0 0 0 0 0 0 1
2 0 0 0 1 0 0 2
3 0 0 0 1 0 0 2
8 d 1 0 0 0 0 0 0 0 0
2 0 0 0 0 0 0 0
3 0 0 0 0 0 0 0
mean 24 -72 h 1 0.00   0.00 0.33 0.00      
mean 24 -72 h 2 0.00   0.00 1.33 0.33      
mean 24 -72 h 3 0.00   0.00 1.67 0.33      
mean 24 -72 h all 0.00   0.00 1.11 0.22      

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Classification: not irritating
Executive summary:

One tenth millitre of the unchanged test substance was instilled into the conjunctival sac of the right eye of each of 3 rabbits without rinsing. The eyes were scored at 1 h, 24 h, 48 h, 72 h, and 8 d after instillation. Findings were evaluated according to the Draize scheme. The untreated left eye of each rabbit served as control.

No effects were seen at the cornea and iris. Redness (up to grade 2, well defined) of the conjunctivae was noted up to 72 h; swelling of the conjunctivae and secretion was noted up to 24 h. All eyes were normal by day 8.