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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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other: Non-GLP similar to guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ephedrine
EC Number:
206-080-5
EC Name:
Ephedrine
Cas Number:
299-42-3
Molecular formula:
C10H15NO
IUPAC Name:
2-(methylamino)-1-phenylpropan-1-ol
Details on test material:
- Name of test material (as cited in study report): (-)-ephedrin, wasserhaltig

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler 6050 Offenbach/Main
- Weight at study initiation: 2.65-3.13 kg
- Housing: 1 animal per cage, stainless steel cage with wire mesh flooring, floor space: 40 cm x 51 cm, no bedding in cages, sawdust in the waste trays.
- Diet: 130 mg per animal per day, Ovator Solikanin 4MM; Muskator-Werke 4000 Dusseldorf
- Water: 250 mL per animal demineralized water on workdays, and 250 mL per animal tap water on free days
- Acclimation period: ca. 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -26
- Humidity (%): 50 - 80
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 mL bulk volume (ca. 31 mg of the test substance) applied to the conjunctival sac of the right eyelid
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- No removel of the substance

SCORING SYSTEM:
- According Draize J.H. et al. (1959)
- Scoring performed 1, 24, 48, 72 hours and 8 days after removal of the test substance

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals (all same score)
Time point:
other: 24, 48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: No observation at timepoint 72 hours because of substance-related coloring of the eye
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: No observation at timepoint 48 and 72 hours because of substance-related coloring of the eye
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 24 - 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 24 - 72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 h
Score:
0.3
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: No observation at timepoint 72 hours because of substance-related coloring of the eye
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 2 animals (all same score)
Time point:
other: 24, 48 h
Score:
0.7
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: No observation at timepoint 72 hours because of substance-related coloring of the eye
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 24 h
Score:
0
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: No observation at timepoint 48 and 72 hours because of substance-related coloring of the eye
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 2 animals
Time point:
other: 24 - 72 h
Score:
0.7
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals (all same score)
Time point:
other: 24, 48 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: No observation at timepoint 72 hours because of substance-related coloring of the eye
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 h
Score:
2.5
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: No observation at timepoint 72 hours because of substance-related coloring of the eye
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24 - 72 h
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 24 - 72 h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
2.3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals (all same score)
Time point:
other: 24 - 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 2 animals (all same score)
Time point:
other: 24 - 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
Suppuration was observed in all animals from 72 h after exposure until the end of the study. Scars were observed in 3 out of 6 animals at the 48 and 72 hours after exposure, this increased to 5 animals 8 days after exposure. Signs of corrosion in the nictating membrane were observed 8 days after exposure.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Conclusions:
Under the conditions of the test, the substance is considered to be corrosive to the eye.
Executive summary:

The potential to cause damage to the conjunctiva, iris and/or cornea was assessed in a similar to OECD 405 guideline study in 6 white Vienna rabbits subjected to a single ocular application of 0.1 mL of the test substance on day 0. Effects on conjunctiva, iris and cornea were observed. Findings were not reversible within 8 days. Scars were also observed 8 days after exposure. It was concluded that the test substance causes severe eye damage.