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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Adopted according to OECD SIDS (publicly available peer reviewed source). Original document not available.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
SIDS Initial Assessment Report For SIAM 20 (Malonic Acid Diesters: Dimethylmalonate, 108-59-8; Diethylmalonate, 105-53-3), April 19-22, 2005 Paris.
Author:
OECD SIDS
Year:
2005
Bibliographic source:
UNEP Publications
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl malonate
EC Number:
203-597-8
EC Name:
Dimethyl malonate
Cas Number:
108-59-8
Molecular formula:
C5H8O4
IUPAC Name:
dimethyl malonate
Details on test material:
Purity: ca. 99 %
Impurities from the production process: methanol (ca. 0.3 %) and dimethyl-methylmalonate (ca. 0.2%)
Physical state: liquid, colorless

Test animals / tissue source

Species:
rabbit
Strain:
other: Small white Russian, Chbb: HM, SPF
Details on test animals or tissues and environmental conditions:
Sex: male
Source: Fa. Dr. Karl Thomae GmbH, Biberach
Weight at study initiation: 2 - 3 kg
Number of animals: 3
Control: untreated second eye of the animals

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated second eye
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scheme

TOOL USED TO ASSESS SCORE: Investigation of intactness of the eyes prior to the experiment and 24 h, 48 h, 72 h, 6 d p.a. with fluorescein.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 6 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: 6 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: All 3 animals had the same scores.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
DESCRIPTION OF LESIONS:
1 h p.a. : Medium grade erythema of the conjunctivae and slight corneal opacity as well as excretion of a white exsudate from the treated eyes was observed in all 3 animals. 2 animals had additionally a very slight edema, one a marked edema.
24 h p.a.: All 3 animals showed medium grade erythema and marked edema of the conjunctivae, indications of an irritation of the iris with intact pupil reaction. The cornea was slightly opaque (in 2 animals the whole area was affected, in 1 animal about half of the area). Exsudation was still observed in one animal.
48 h p.a.: The medium grade erythema was unchanged in all animals, while edema was reduced in 2 animals. 2 animals still showed iridal irritation while it was reduced in one animal. In 2 animals corneal opacity had increased slightly. Exsudation was still observed in one animal.
72 h p.a. : The medium grade erythema was unchanged in all animals, while edema was reversed. Iridal irritation was still observed in one animal. Slight corneal opacity was seen in 2 animals covering one and 3 quarts of the surface respectively while in 1 animal corneal opacity was still unchanged.
6 d p.a. : Corneal and iris reactions were reversed completely in all animals, very slight conjunctival irritation and chemosis was observed in 2 animals.
8 d p.a.: All effects were reversible by day 8.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information (Category 2)