Glycerol monomyristate

Endpoint summary

Description of key information

Skin, rabbit: not irritating

Eye, rabbit: not irritating

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:

06 - 10 Mar 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No details on analytical purity of the substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

no details on analytical purity of the substance

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Supplier, Saint-Aubin-Les-Elbeuf, France
- Age at study initiation: not reported
- Weight at study initiation: > 1.8 kg
- Housing: individually in stainless steel cages on floor grid
- Diet: pellets (Ergilap Anco, COFNA, France), ad libitum
- Water: tap water (periodically analysed chemicophysically and bacteriologically), ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light):12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: mineral oil

Controls:

other: vehicle alone on different site of the treated animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g soaked with 0.25 mL mineral oil

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.25 mL
- Lot/batch no.: Sigma batch 116 H 1202

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm² of the dorsal area of the trunk
- Type of wrap if used: the gauze patch was put on a Micropore tape of 5 cm x 5 cm and the semi-occlusive dressing was held in place with an extensible bandage (type of varicose vein bandage) fixed with Micropore.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed using a cotton wool with water or an appropriate solvent.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Slight erythema was observed in 2 of 3 animals 24 and 48 h after patch removal, which was fully reversible within 48 and 72 h, respectively. In the third animal no erythema was observed. No oedema occurred in any of the tested animals and no skin reactions were observed on the control sites of the animals treated with the vehicle alone.

Other effects:

All animals showed the expected increase in body weight. No clinical signs of toxicity were observed.

The vehicle alone caused no skin reactions in any of the animals at any reading timepoint.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

CLP: not classified
DSD: not classified

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:

06 - 10 Mar 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No details on analytical purity of the substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

no details on analytical purity of the substance

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Supplier, Saint-Aubin-Les-Elbeuf, France
- Age at study initiation: not reported
- Weight at study initiation: > 1.8 kg
- Housing: individually in stainless steel cages on floor grid
- Diet: pellets (Ergilap Anco, COFNA, France), ad libitum
- Water: tap water (periodically analysed chemicophysically and bacteriologically), ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light):12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g, ground to a fine dust using a pestle in a mortar

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

3 males

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein after 24 h observation

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Slight to moderate redness of conjunctivae occurred in all three tested animals, which was fully reversible within 72 h. At the 1 h reading time point, slight chemosis was observed in all animals, and persisted in 2 of 3 tested animals up to 24 h after test substance instillation. However, chemosis was fully reversible within 48 h in all animals.

Other effects:

During the 72-h observation period, no clinical signs of toxicity were noted in the treated animals.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

CLP: not classified
DSD: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

Glycerol monomyristate (CAS 27214 -38 -6) was tested for its skin irritation potential according to OECD Guideline 404 and in compliance with GLP (Stearinerie, 2000). Three New Zealand White rabbits were exposed to 0.5 g of the crunched test substance in mineral oil for 4 h under semi-occlusive conditions. The vehicle was similarly applied to the other site of the animals and served as control. Skin reactions were assessed using the Draize scheme 24, 48 and 72 h after removal of the test substance. Slight erythema was observed in 2 of 3 animals 24 and 48 h after patch removal, which was fully reversible within 48 and 72 h, respectively. In the third animal no erythema was observed. No oedema occurred in any of the tested animals and no skin reactions were observed on the control sites of the animals treated with the vehicle alone. All animals showed the expected increase in body weight and no clinical signs of toxicity were observed during the experiment. The individual mean erythema scores over the 24, 48 and 72 h reading time points were 0.3/0/0.7 and edema scores were 0 for the 3 animals, respectively. Thus, the test substance is considered to be non-irritating to the skin.

 

Eye irritation/corrosion

Glycerol monomyristate (CAS 27214 -38 -6) was tested for its eye irritation potential according to OECD guideline 405 and in compliance with GLP (Stearinerie, 2000). The solid test material (0.1 g) was ground to a fine dust and instilled into the conjunctival sac of one eye of three New Zealand White rabbits each. Examination of the effects on the eyes was scored 1, 24, 48 and 72 h after test substance instillation according to the method of Draize. Slight to moderate redness of conjunctivae occurred in all three tested animals, which was fully reversible within 72 h. At the 1 h reading time point, slight chemosis was observed in all animals, and persisted in 2 of 3 tested animals up to 24 h after test substance instillation. However, chemosis was fully reversible within 48 h in all animals.During the 72-h observation period; no clinical signs of toxicity were noted. The mean cornea and iris scores after 24, 48, and 72 h were 0 for all 3 animals. The mean scores for conjunctivae and chemosis over 24, 48, and 72 h were 1/1/0.7 and 0/0.3/0.3 for the 3 individual animals, respectively. Thus, the test substance was not considered as eye irritant.

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that "substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Glycerol monomyristate, data will be generated from data available for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

The available data on skin and eye irritation/corrosion do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.