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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June - August 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
scientifically acceptable method was used and adequately reported, similar to OECD 405, no GLP, only 10 µL test item was administered, considered reliable with restrictions because results lead to classification and classification is identical to the chemically very similar 1,2-pentanediol

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Standard method for Evaluation of Eye Irritation in Albino Rabbits, E 1055-85, ASTM
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
DL-hexane-1,2-diol
EC Number:
230-029-6
EC Name:
DL-hexane-1,2-diol
Cas Number:
6920-22-5
Molecular formula:
C6H14O2
IUPAC Name:
hexane-1,2-diol
Constituent 2
Reference substance name:
1,2-hexanediol
IUPAC Name:
1,2-hexanediol
Test material form:
other: colourless liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Adult, New Zealand Whlte rabbltw were received at SLS from Myrtle‘s Rabbitry, Thompson Station, TN. Upon receipt, plastic ear tags displaying
unique identication numbers were used to individually identity the animals. Cage cards displaying at least the study number, animal number and sex
were affixed to each cage. The animals were housed individually in suspended stainless steel cages. AlI housing and care were based on the
standards recommended by the Guide for the Care and Use of Laboratory Animals.
The animal room temperature and relave humidity ranges were 65-72 °F and 50-73%. respectively. Environmental control equipment was monitored
and adjusted as necessary to minimize uctuations in the animal room environment. Light timers were set to maintain a 12-hour light/12-hour dark
cycle and room ventilation was set to produce 10-15 airchanges per hour. The animal room temperature and relative humidity were recorded a minimum of once daily.
Animals were acclimated, water and food was controled and animal selection for test was performed randomly.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: second eye of each animal used as control
Amount / concentration applied:
100% concentration, 10 µl per animal eye
Duration of treatment / exposure:
Following macroscopic observations t the 24-hour scoring interval, the fluorescein examintion procedure was repeated on all test and control eyes and any residual test article was gently rinsed from the eye at this time (if possible) with physiological saline.
Observation period (in vivo):
Any unusual observations or mortality were recorded. Mortality checks were performed twice dily, in the morning and afternoon. Scores were taken 1, 24, 48 and 72 hours following start of exposure as well as on days 4, 7, 10 and 14 when last score returned to 0.
Number of animals or in vitro replicates:
3 animals (1 male and 2 females) were used for this experiment

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 10 days
Other effects:
Fluorescein retention was associated with the areas of corneal opacity. At 1 hour readings corneal epitelial tissue was observed to be peeling of the corneal surface.

Any other information on results incl. tables

Exposure to the test article produced corneal opacity in 3/3 test eyes at the1 -hourr scoring interval. The corneal opacity was confirmed by positive fluorescein dye retention at the 24 hour scoring interval. The corneal injury resolved in all test eyes by study day 14. Iritis was observed in 3/3 test eyes at the 1 hour scoring interval and resolved in all test eyes by day 7. Conjunctivitis and chemosis was noted in 3/3 test eyes at the 1 -hour scoring interval. The effects resolved completely in all test eyes at study day 10.

No mortality was observed during the study.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance 1,2-hexanediol was shown to be irritant to rabbit eyes in this test according to ASTM method E 1055-85.
Executive summary:

Exposure to the test article produced corneal opacity in 3/3 test eyes at the1 -hourr scoring interval. The corneal opacity was confirmed by positive fluorescein dye retention at the 24 hour scoring interval. The mean score for the 24, 48 and 72 hour scoring interval was 2 (max. score 4) and therefore qualifies this result as irritating to eyes, Category 2 according to CLP (Regulation (EC) No 1272/2008). The corneal injury resolved in all test eyes by study day 14. Iritis was observed in 3/3 test eyes at the 1 hour scoring interval and resolved in all test eyes by day 7. The mean score for the 24, 48 and 72 hour scoring interval was 0.89 (max. score 2).

Conjunctivitis and chemosis was noted in 3/3 test eyes at the 1 -hour scoring interval. The effects resolved completely in all test eyes at study day 10. The mean score for the 24, 48 and 72 hour scoring interval was 1.78 for conjunctivitis and chemosis (max. score 3 respectively 4)