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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1976-11-22 to 1976-11-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977
Reference Type:
other: raw data related to study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Company guideline previous to OECD guideline implementation that is similar to OECD 405
Deviations:
not applicable
Qualifier:
according to guideline
Guideline:
other: Federal Register Vol. 38, No 187, p 27019, 1973
Deviations:
not specified
Principles of method if other than guideline:
Mucosal tolerance was assessed after single application of 0.1mL of undiluted liquid test substance directly into the conjunctival sac of the left eye of six rabbits. The right eye remained untreated and served as a control. The experiment was conducted according to FDA directives (Federal Register Vol. 38, No 187, p 27019, 1973).
Evaluation was conducted 1, 7, 24, 48 and 72hrs after treatment by using a magnifying glass. 24hrs after treatment eyes were thoroughly washed with physiological sodium chloride solution. To assess the 48 and 72hrs time points a drop of a 0.01% sodium fluorescein solution was instilled into the eyes. Gradings of eye reactions were recorded according to Appraisal of the Safety of Chemicals in Foods, Drugs and Cometics, FDA, Austin, Texas, p. 51, 1975.
GLP compliance:
no
Remarks:
- Performed prior to GLP implementation.

Test material

Constituent 1
Chemical structure
Reference substance name:
1-chloro-2,5-dimethoxybenzene
EC Number:
218-267-9
EC Name:
1-chloro-2,5-dimethoxybenzene
Cas Number:
2100-42-7
Molecular formula:
C8H9ClO2
IUPAC Name:
2-chloro-1,4-dimethoxybenzene
Details on test material:
- Name of test material (as cited in study report): CME = Chlorhydrochinondimethyläther (2-Chlor-1,4-dimethoxybenzol)

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
- SPF-Albino-Himalayan-rabbits (strain HOE:HIMK(SPFWiga)) were used as experimental animals
- Animals were kept in single cages
- Food (ERKA 8300, company: Futtermittelwerke Robert Koch oHG, Hamm) and tap water were supplied ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1mL of undituted CME
Duration of treatment / exposure:
24hrs
Observation period (in vivo):
72hrs
Number of animals or in vitro replicates:
Six rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: mean of animal 1, 2, 3, 4, 5, 6 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
other: Initial, slight effects were fully reversible within 24h
Irritation parameter:
iris score
Basis:
other: mean of animal 1, 2, 3, 4, 5, 6 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
other: Initial, slight effects were fully reversible within 24h
Irritation parameter:
conjunctivae score
Basis:
other: mean of animal 1, 2, 3, 4, 5, 6 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
other: Initial, slight effects were fully reversible within 24h
Irritation parameter:
chemosis score
Basis:
other: mean of animal 1, 2, 3, 4, 5, 6 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Reversibility:
other: Initial, slight effects were fully reversible within 24h
Irritant / corrosive response data:
Cornea score (mean of 24, 48 and 72 h)
Animal #: 1/2/3/4/5/6:
0.0/0.0/0.0/0.0/0.0/0.0

Iris score (mean of 24, 48 and 72 h)
Animal #: 1/2/3/4/5/6:
0.0/0.0/0.0/0.0/0.0/0.0

Conjunctivae Redness score (mean of 24, 48 and 72 h)
Animal #: 1/2/3/4/5/6:
0.0/0.0/0.0/0.0/0.0/0.0

Conjunctivae Chemosis score (mean of 24, 48 and 72 h)
Animal #: 1/2/3/4/5/6:
0.0/0.0/0.0/0.0/0.0/0.0

Initial, slight effects were fully reversible within 24h

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the findings in this test the test substance is not eye irritating.
Executive summary:

CME was tested for eye irritanting properties according a company guideline similar to OECD 405. Following these protocol 0.1 ml of the undiluted test substance was applied into the conjunctival sac of the left eye of six rabbits. The right eye remained untreated and served as a control. After 24 h exposure time the eye was rinsed with physiological saline. The eyes of the animals were examined at 1, 7, 24, 48, and 72 h after test substance application. Mean scores (mean of 24, 48, 72h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each animal.

Based on the findings in this test the test substance is not eye irritating.