3-Methoxy-3-methylbutyl acetate

Endpoint summary

Description of key information

Skin irritation – slight irritant effect seen in New Zealand White rabbits, although not sufficient for classification.  Max erythema score – 1, reversible within 48 hours.  No edema observed.

Eye irritation – slight irritant effect seen in New Zealand White rabbits, although not sufficient for classification.  Conjunctivae score of 1 seen in all rabbits at 1 hour; minor iris lesions and chemosis seen in one rabbit at 1 hour, but all irritant effects were reversible within 24 hours of instillation.

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:

1992-07-14 to 1992-07-17

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study report is of good quality and the study was conducted to GLP and documented test parameters are based on specific national guidelines, the purity of test substance is not reported and actual test guideline references are not quoted in test report.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

The study report states that the methodology used met OECD and EEC guidelines.

GLP compliance:

yes

Remarks:

The study report contains a statement of Quality Assurance, and a statement of GLP compliance, but no formal GLP certificate issued by a competent authority or other official body was provided.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Limited, Abbots Ripton Road, Wyton, Huntingdon, Cambs, PE17 2DT.
- Weight at study initiation: 3.2-3.5kg
- Housing: Individually in aluminium cages with grid floors beneath which were absorbent paper lined trays
- Diet (e.g. ad libitum): ad libitum Standard Rabbit Diet, supplied by Special Diets Services Limited, 1 Stepfield, Witham, Essex, CM8 3AD,
- Water (e.g. ad libitum): ad libitum tap water
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): mean 47
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5ml

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 h after patch removal

Number of animals:

3

Details on study design:

TEST SITE
- 6cm2 of skin
- Type of wrap if used: Gauze patch, held in place by micropore tape, bound with elastoplast elastic bandage

REMOVAL OF TEST SUBSTANCE
- Skin wiped with water dampened tissue to remove surplus test material
- Time after start of exposure: 4 hours

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 hour

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 48 Hours

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

ca. 0

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

ca. 0

Max. score:

0

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 hour

Score:

ca. 0

Max. score:

0

Reversibility:

other: Not applicable as no edema seen.

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: Not applicable as no edema seen.

Irritant / corrosive response data:

Very slight erythema (score 1) was noted at all test sites at the 1h and 24 h assessments. Full recovery was noted 48 h after patch removal. No oedematous responses were noted at any time during the study.

Interpretation of results:

not irritating

Remarks:

Migrated information Although the study concluded that the test material was slightly irritating, when assessed according to Directive 67/548/EEC, the results do not indicate classification as irritating. Criteria used for interpretation of results: EU

Conclusions:

MMB-Ac is slightly irritant to rabbit skin.

Executive summary:

The acute dermal irritation potential of a test material, MMB-Ac, was investigated in 3 New Zealand White rabbits. Very slight erythema (score I) was noted at all test sites at the 1 h and 24 h assessments, with full recovery noted at 4B h after patch removal. MMB-Ac is slightly irritant to rabbit skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

A skin irritation study was conducted to determine the skin irritant effects of the test material. The study was conducted in compliance with GLP, and the methodology used was broadly consistent with modern test guidelines. Three New Zealand White rabbits were clipped of hair on a portion of their backs, and 0.5 mL of the liquid test substance was applied for 4 hours. The test substance was held in place by use of a gauze patch. At the end of the exposure period, the test material was removed with a water dampened tissue. The application site was assessed for signs of irritation 1, 24, 48, and 72 hours after the removal of the patch.

A maximum erythema score of 1 (very slight erythema) was seen in all animals at 1 hour and 24 hours following patch removal, however this was fully reversible within 48 hours. No oedematous responses were seen.

It was concluded that the test substance was slightly irritant to rabbit skin.

Eye irritation

A eye irritation study was conducted to determine the eye irritant effects of the test material. The study was conducted in compliance with GLP, and the methodology used was broadly consistent with modern test guidelines. The 0.1 mL of the liquid test material was instilled into one eye of each of three New Zealand White rabbits; the other eye of each animal was left untreated as a control. The animals were visually assessed using a hand magnifier and torch 1, 24, 48, and 72 hours after instillation.

Conjunctival redness (score = 1) was seen in all animals, and iris lesions and chemosis was seen in one animal (score = 1) at the 1 hour timepoint. In each case the observations were not severe, and the irritant effects were fully reversible within 24 hours of test material instillation.

The test material was concluded to be slightly irritating to rabbit eyes.

Justification for classification or non-classification

In the skin irritation test, a maximum erythema score of 1 was seen, which fully reversed within 48 hours of exposure. In the eye irritation test, a maximum conjunctivae score of 1 was seen in all animals, and iris irritancy and chemosis were only seen in 1 of 3 animals, and all irritant observations were fully reversible within 24 hours.

On the basis of these results, the test material does not meet the criteria for classification as either a skin or eye irritant as described in either the Dangerous Substances Directive (67/548/EEC) or in the Classification, Labelling and Packaging Regulation (EC Regulation 1272/2008).