DL-hexane-1,2-diol

Endpoint summary

Description of key information

Skin corrosion/irritation: non-irritant
Eye corrosion/damage: eye irritating (Category 2 CLP)
Respiratory irritation: No data

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26.9.1980-30.09.1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Pre OECD and pre-GLP study but well conducted according to draft OECD protocol.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Remarks:

Draft guideline used of 1981 version

GLP compliance:

no

Species:

rabbit

Strain:

other: Russian Albino

Details on test animals or test system and environmental conditions:

3 male and 3 female test animals were used, approx. 1 year of age. the animals were acclimized for 1 day. Animals were individually housed in stainless steel cages, receiving standardised food (Altromin) and water ad libitum. Room temperature was 22 ±1 °C and relative humidity 50-60% during the test period. A 12 hour light/12 hour dark period was maintained per day. cages were cleaned and desinfected prior to use.

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: Traganth

Controls:

other: other areas on animal skin, treated equivalently but without test substance

Amount / concentration applied:

0.5 ml test substance were suspended in 500 mg Traganth to ensure adsorption to skin without losses.

Duration of treatment / exposure:

72 hours

Observation period:

observation period post exposure was scheduled for 14 days but was not required

Number of animals:

3 female and 3 male

Details on study design:

both flanks of each animal were used, whereas the left side was exposed as is (clipped) and the right side clipped and artificially sacrifized at the skin surface avoiding bleeding and deeper skin lessions.
The test substance was applied for 4 hours and scores (according to Draize) were taken 1, 24, 48 and 72 hours following removal of the patches.

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: sacrificed skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: sacrificed skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: sacrificed skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: sacrificed skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

4

Remarks on result:

other: sacrificed skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

4

Remarks on result:

other: sacrificed skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 h

Score:

0

Max. score:

4

Remarks on result:

other: sacrificed skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

4

Remarks on result:

other: sacrificed skin

Irritant / corrosive response data:

A single application of 0.5 ml 1,2-hexanediol was tolerated almost without reaction. Only animals 1, 2 and 6 showed a defined erythrem 1 hour following removal of patches (score 2), which disappeared almost entirely at the end of the 72 hour observation period. Thus, the substance is considered non-irritant. Systemic toxic effects were not observed and animal behaviour was normal. The pure vehicle applied as control was tolerated without any reaction.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance 1,2-hexanediol is not irritating to rabbit skin.

Executive summary:

A single application of 0.5 ml 1,2-hexanediol was tolerated almost without reaction. Only animals 1, 2 and 6 showed a defined erythrema 1 hour following removal of patches (score 2), which disappeared almost entirely at the end of the 72 hour observation period. Thus, the substance is considered non-irritant. Systemic toxic effects were not observed and animal behaviour was normal. The pure vehicle applied as control was tolerated without any reaction.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

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)

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.

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

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.

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.

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)

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Effects:

A single application of 0.5 ml 1,2-hexanediol was tolerated almost without reaction. Only animals 1, 2 and 6 showed a defined erythrem 1 hour following removal of patches (score 2), which disappeared almost entirely at the end of the 72 hour observation period. Thus, the substance is considered non-irritant. Systemic toxic effects were not observed and animal behaviour was normal. The pure vehicle applied as control was tolerated without any reaction.

Eye effects:

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). Respiratory irritation: No study is available

Justification for selection of eye irritation endpoint:
only study available

Effects on eye irritation: irritating

Justification for classification or non-classification

The test substance was shown to be non-irritant in a study with application to rabbit skin and therefore does not require classification for skin corrosion/irritation according to CLP (Regulation (EC) No 1272/2008).

Due to the reversible corneal effects in the eye irritation study (mean score for the 24, 48 and 72 hour scoring interval was 2 (max. score 4)) the substance fulfills the criteria for classification Eye Damage, Category 2 according to CLP (Regulation (EC) No 1272/2008).

No information regards respiratory irritation is available and therefore the substance is not to be classified for this endpoint due to lack of data.