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Diss Factsheets

Toxicological information

Eye irritation

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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:
comparable to guideline study with acceptable restrictions

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)
Deviations:
yes
Remarks:
the test was terminated at post-application day 15, when effects were not completely reversed
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was performed

Test material

Constituent 1
Chemical structure
Reference substance name:
2-phenoxyethanol
EC Number:
204-589-7
EC Name:
2-phenoxyethanol
Cas Number:
122-99-6
Molecular formula:
C8H10O2
IUPAC Name:
2-phenoxyethan-1-ol
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2-Phenoxyethanol (technical grade)
- Analytical purity: no data
- Lot/batch No.: substance number: 83/143
- Expiration date of the lot/batch: May 1984

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Firma Gaukler; Offenbach, Germany
- Age at study initiation:
- Weight at study initiation: 2.51 kg, 2.37 kg, 2.61 kg
- Housing: single housing in stainless-steel cages
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm, Muskator-Werke Duesseldorf, Germany
- Water (e.g. ad libitum): drinking water
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
The substance remained in the eye, therefore 15 days.
Observation period (in vivo):
15 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: according to OECD and Draize

Corneal Opacity (maximum possible: 4)
0 = no finding
1 = slight opacity
2 = well-defined opacity
3 = severe opacity
4 = very severe opacity

Involved corneal area
1 = > 0 - < ¼
2 = >= 1/4 - < ½
3 = >= ½ - < ¾
4 = >= 3/4

Iris (maximum possible: 2)
0 = no finding
1 = ciliary injection
2 = iritis

Conjunctival redness (maximum possible: 3)
0 = no finding
1 = slight redness
2 = well-defined redness
3 = severe redness

Conjunctival swelling (maximum possible: 4)
0 = no finding
1 = slight swelling
2 = well-defined swelling
3 = severe swelling
4 = very severe swelling

Secretion (maximum possible: 3)
0 = no finding
1 = slight increase
2 = well-defined increase
3 = severe increase

Calculation of the irritation index:
For each animal and each reading time point, the irritation index (I) was calculated according to following formula:
I = A + B + C
A = 5 x opacity x involved corneal area
B = 5 x iris
C = 2 x (conjunctival redness + swelling + secretion)

The primary irritation index (PI) was the sum of all irritation indices for all animals and all reading time points (24, 48 and 72 h), subdivided by 3 x the number of animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
0
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: occurence of effects after 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 15 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Reversibility:
fully reversible within: 15 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: occurence of effects after 24 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Reversibility:
fully reversible within: 15 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Reversibility:
fully reversible within: 8 days
Other effects:
Additional symptoms such as narrowness of pupil, scarred retraction of eyelid, marginal corneal vascularisation and suppuration were also considered.
No clinical signs observed.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
A tendency to reversibility was observed but after the exposure period (15 days), one animal still displayed slight corneal opacity affecting less than ¼ of the corneal area of the treated eye. In the CLH report on the Proposal for Harmonised Classification and Labelling for Phenoxyethanol (June 2018), an additional study in rabbits acc. to OECD 405 was cited, that also showed persistent corneal opacity in 1/6 animals on observation day 21 after phenoxyethanol administration. Here, it was proposed to classify for irreversible effects to the eye, category 1, on the basis that at least one animal had effects to the cornea that were not fully reversed within the observation period of 21 days.