3,7-dimethyloctane-1,7-diol

Endpoint summary

Description of key information

In a study with rabbits, the dermal occlusive application of 5 mL test item/kg bw over 24 hours onto intact and abraded skin caused only very mild erythema.

Three NZW rabbits were subjected to a single ocular application of 0.1 mL test item. The average score for irritation (24 h-72 h) was 0.3 for corneal opacity, 0.2 for iris, 2.1 for conjuntivae redness and 0.8 for chemosis. All effects were reversible within 8 d. Therefore, the test item can be classified as mildly irritating to eyes based on GHS criteria.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1972-1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

other: albino

Details on test animals or test system and environmental conditions:

Four normal, healthy, albino rabbits, weighing 2 - 3.5 kg, were used in this study. The animals had been acclimated to laboratory conditions for at least two weeks prior to being placed on test. Prior to placing the animals on test their backs were clipped free of all hair with small animal clippers. The backs were further prepared by making epidermal abrasions every two to three cm, longitudinally, over the clipped area of exposure.
The test material, at a level of 5 ml. per kilo, was applied to the clipped intact and abraded skin areas. These areas were covered with a rubber sleeve or dam which fit snuggly around each animal. The animals were then placed in a multiple animal holder and held there for a twenty-four hour period. During this time each test animal was allowed its daily ration of rabbit pellets and water.
Following the twenty-four hour exposure period the rubber sleeves were removed from the test animals and skin reactions recorded. Each animal was thoroughly wiped down and returned to its own metabolism cage to be observed for a fourteen day period.

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded skin

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

5 mL/kg

Duration of treatment / exposure:

24 h

Observation period:

up to 14 days

Number of animals:

4

Details on study design:

Single application of 5 mL/kg onto intact and abraded skin, occlusive dressing over 24 hrs, readings at patch removal

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Irritation parameter:

other: eschar score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Interpretation of results:

GHS criteria not met

Conclusions:

In this study with rabbits, the dermal occlusive application of 5 mL test item/kg bw over 24 hours onto intact and abraded skin caused only very mild erythema.

Executive summary:

In this study with rabbits, the dermal occlusive application of 5 mL test item/kg bw over 24 hours onto intact and abraded skin caused only very mild erythema.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: DR . K . THOMAE GMBH, BIBERACH, FRG
- Age at study initiation: YOUNG ADULT ANIMALS
- Weight at study initiation: 3.00-3.38 kg
- Housing: single housing
- Diet (e.g. ad libitum): ABOUT 250 ML TAP WATER PER ANIMAL PER DAY
- Water (e.g. ad libitum): KLIBA-LABORDIAET 341, KLINGENTALMUEHLE AG, KAISERAUGST, SWITZERLAND, (ABOUT 130 G PER ANIMAL PER DAY)
- Acclimatization period: at least 1 wk

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: negative control: untreated eye

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

24 h

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1/24/48/72h and 8 d

Score:

0.3

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1/24/48/72h and 8d

Score:

0.2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Time point:

other: 1/24/48/72 h and 8 d

Score:

2.1

Max. score:

3

Reversibility:

fully reversible

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Conclusions:

Due reversible of conjunctivae redness (score >=2) a classification of Category 2B is justified.

Executive summary:

Three White New Zealand were subject to a single ocular application of 0.1 mL. The average score for irritation (24 h-72 h) was 0.3 for corneal opacity, 0.2 for iris, 2.1 for conjuntivae redness and 0.8 for chemosis. All effects were reversible within 8 d.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In a study with rabbits, the dermal occlusive application of 5 mL test item/kg bw over 24 hours onto intact and abraded skin caused only very mild erythema.

Three NZW rabbits were subjected to a single ocular application of 0.1 mL test item. The average score for irritation (24 h-72 h) was 0.3 for corneal opacity, 0.2 for iris, 2.1 for conjuntivae redness and 0.8 for chemosis. All effects were reversible within 8 d. Therefore, the test item can be classified as mildly irritating to eyes based on GHS criteria.