2-ethyl-2-(hydroxymethyl)propane-1,3-diol, propoxylated, reaction product with methyl 3-oxobutanoate

Endpoint summary

Description of key information

A well-conducted Acute Dermal Irritation/ Corrosion test (OECD 404) was performed on rabbits with the test substance. Under the conditions of the test no signs of skin irritation could be observed 24, 48 and 72 hours after exposure (4 hours). 
A well-conducted Acute Eye Irritation/ Corrosion test (OECD 405) was performed with the test substance. Under the conditions of the test only slight irritating effects were observed (conjunctivae redness score 1 after 24 hours, fully reversed after 48 hours). 

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(2002)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

other: albino, CRL:KBL(NZW)BR

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Sex: females
- Source: Charles River, Kißleg, Germany
- Age at study initiation: young adult animals
- Diet and water: ad libitum
- Acclimation period: at least 5 days

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: The surrounding untreated skin served as control

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

Until changes had completely subsided, however for not more than 14 days after application.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approximately 6 cm² on the dorso-lateral areas of the trunk of each animal
- Type of wrap if used: non-irritant tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): careful washing with water without altering the existing response or the integrity of the epidermis
- Time after start of exposure: 4 h

SCORING SYSTEM: as specified by Draize

Irritation parameter:

erythema score

Remarks:

(redness and eschar formation)

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Other effects:

The control areas did not show any abnormal findings.
There were no systemic intolerance reactions.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Executive summary:

A well-conducted Acute Dermal Irritation/ Corrosion test (OECD 404) was performed on rabbits with the test substance. Under the conditions of the test no signs of skin irritation could be observed 24, 48 and 72 hours after exposure (4 hours). There were no systemic intolerance reactions.

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(2002)

Principles of method if other than guideline:

This testing strategy comprised a stepwise approach including the evaluation of existing human and/or animal data showing effects on the eye or the skin, the performance of a SAR evaluation for eye and skin corrosion/irritation, measurement of pH value, the evaluation of data on systemic toxicity via the dermal route, the performance of a validated in vitro test for skin corrosion (Human 3D Epidermal Skin Model) and in vivo testing for skin irritation/corrosion in rabbits before in vivo testing for eye irritation/corrosion in rabbits.

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Strain: Crl:KBL(NZW)BR
- Sex: male
- Source: Charles River, 88353 Kißleg, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 3.0-3.5 kg
- Housing: individually in cage units Metall/Noryl by EBECO
- Diet and water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 25
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Vehicle:

unchanged (no vehicle)

Controls:

other: The other eye, which remained untreated, served as control.

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

The lids were gently held together for about one second in order to prevent loss of the test compound. The eye was rinsed with saline approximately 24 hours following instillation.

Observation period (in vivo):

Animals were monitored after application until the changes had completely subsided, however for not more than 21 days after application.

Number of animals or in vitro replicates:

3

Details on study design:

0.1 ml of the pure liquid test substance was placed into the conjunctival sac of one eye of the first animal after having gently pulled the lower lid away from the eyeball. The lids were gently held together for about one second in order to prevent loss of the test compound.
Because of the fact that one hour after treatment a severe irritation was not observed, a further two rabbits were treated as described.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eye was rinsed approximately 24 hours following instillation.

SCORING SYSTEM: Draize

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

#1, #2

Time point:

other: 24, 48, 72 hours

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: grade 1 redness at 24 h only

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

#3

Time point:

other: 24, 48, 72 hours

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: grade 1 redness at 24 and 48 h

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Other effects:

The control eyes did not show any abnormal findings.
There were no systemic intolerance reactions.

Executive summary:

A well-conducted Acute Eye Irritation/ Corrosion test (OECD 405) was performed with the test substance. Under the conditions of the test only slight irritating effects were observed (conjunctivae redness score 1 after 24 hours, fully reversed after 48 hours). There were no systemic intolerance reactions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Justification for selection of skin irritation / corrosion endpoint:
only one in vivo study available

Justification for selection of eye irritation endpoint:
only one in vivo study available