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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

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: Adequately reported study using a recognised test method (test group size larger than specified in relevant OECD guideline).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
6 test animals plus extra 3 given eyewash 30 seconds post-treatment
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
-
EC Number:
439-070-6
EC Name:
-
Cas Number:
125005-87-0
Molecular formula:
Not applicable
IUPAC Name:
(2R,3R,4S,5S)-2,3,4,5-tetrahydroxyhexanal (2R,3S,4R,5R)-2,3,4,5,6-pentahydroxyhexanal (2S,3S,4S,5R)-2,3,4,5-tetrahydroxy-6-oxohexanoic acid acetic acid calcium dihydride hydrate magnesium dihydride potassium hydride sodium hydride

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
Adult

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Eyes checked pre-treatment, then untreated eye of each animal served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Single ocular administration (eyewash with water after 30 seconds for 3 rabbits in the extra group)
Observation period (in vivo):
24, 48 and 72 hours post-treatment.
Number of animals or in vitro replicates:
6 (plus 3 in extra eyewash group)
Details on study design:
Single treatment (eyewash for the extra group) followed by observations.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals (unwashed)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
conjunctivae score
Remarks:
Redness and Discharge
Basis:
mean
Remarks:
6 animals (unwashed)
Time point:
72 h
Score:
0
Max. score:
20
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals (unwashed)
Time point:
24/48/72 h
Score:
0
Max. score:
80
Reversibility:
other: No cornea opacity observed
Remarks on result:
other: All scores zero.
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals (unwashed)
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
other: No effects observed
Remarks on result:
other: All scores zero.
Irritation parameter:
conjunctivae score
Remarks:
Redness and discharge
Basis:
mean
Remarks:
6 animals (unwashed)
Time point:
24 h
Score:
4.3
Max. score:
20
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Remarks:
Redness and Discharge
Basis:
mean
Remarks:
6 animals (unwashed)
Time point:
48 h
Score:
0
Max. score:
20
Reversibility:
fully reversible within: 48h
Irritant / corrosive response data:
Transient and minor reaction to treatment only.

Any other information on results incl. tables

Among the 3 additional, eyewashed animals, all scores were zero except for a single case of discharge (score 1), seen at 24h only (fully reversible within 48 hours).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Not classified for eye irritation under EU criteria.