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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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other: Non-GLP guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment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:
1986
Report date:
1986

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis[[R-(R*,S*)]-β-hydroxy-α-methylphenethyl)methylammonium] sulphate
EC Number:
205-154-4
EC Name:
Bis[[R-(R*,S*)]-β-hydroxy-α-methylphenethyl)methylammonium] sulphate
Cas Number:
134-72-5
Molecular formula:
C10H15NO.1/2H2O4S
IUPAC Name:
bis([(1R,2S)-1-hydroxy-1-phenylpropan-2-yl](methyl)azanium) sulfate
Details on test material:
- Name of the test substance used in the study report: (-)-Ephedrin-Sulfat

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, FRG
- Weight at study initiation: mean weight males 2.93 kg and females 2.75 kg
- Housing: 1 animal per cage, stainless steel cages with wire mesh walk floors, floor area : 40 cm x 51 cm; no bedding, saw-dust in the waste trays
- Diet: Kliba 341, 4 MM; Firma Klingentalmuehle AG, C-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: about 250 mL tap water per animal
- Acclimation period: at least 8 days before beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air: fully air-conditioned rooms
- 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 (about 35 mg of the comminuted test substance)
Duration of treatment / exposure:
Single application
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
- Single application to the conjunctival sac ofthe right eyelid; the test substance was not washed out.
- Readings performed 1, 24, 48 and 72 h after application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #2
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal: #1 and #2
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Loss of corneal tissue was observed animal #3 at 24 and 48 hours after exposure.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Under the conditions of the test, the substance was considered to be not irritating to the eye.
Executive summary:

The potential to cause damage to the conjunctiva, iris and cornea was assessed in an OECD 405 guideline study in which 3 Vienna white rabbits were subjected to a single ocular application of 0.1 mL of the test substance on day 0. The mean score (24 to 72 hours) for irritation was calculated to be 0, 0, and 0.7 for corneal opacity, 0, 0, and 0 for iris, 0, 0, and 1 for chemosis, and 1, 1, and 1 for conjunctivae redness, for animal 1, 2, and 3 respectively. Findings were reversible within 72 hours after application. It was concluded that the test substance was not irritating to the eye.