D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates

Endpoint summary

Description of key information

The test item is non-irritating to the skin of rabbits.
The test item is non-irritating to the eyes of rabbits.

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:

10 December 2013 to 21 December 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Adequate in vivo testing carried out for US regulation, hence no in vitro study is provided.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd. Hillcrest, Dodgeford Lane Belton, Loughborough Leics, LE12 9TE / UK
- Age at study initiation: 11 weeks
- Weight at study initiation: 1791 - 1967g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): Pelleted standard Teklad Global High Fiber Rabbit Diet 2031C (batch no. 11/13 provided by Provimi Kliba AG, 4303 Kaiseraugst / Switzerland) ad libitum.
- Water (e.g. ad libitum): Community tap-water from Itingen ad libitumin water bottles.
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18 ± 3 °C
- Humidity (%):30 - 70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light):12 hours light and 12 hours darkness.

IN-LIFE DATES: From: 10 December 2013 To: 21 December 2013

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/animal

Duration of treatment / exposure:

4 Hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 100 cm2
- Type of wrap if used:adhesive hypoallergenic aerated semi-occlusive dressing and a restrainer bandage wrapped around the trunk

SCORING SYSTEM:The skin reaction was assessed according to the numerical scoring system listed in the Commission Regulation (EC) No. 440/2008

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean erythema/eschar and oedema score for each of the three animals was therefore 0.

Other effects:

None

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is considered to be “not irritating” to rabbit skin.

Executive summary:

Introduction

The acute dermal irritation potential of the test item was investigated according to OECD test guideline No. 404, Commission Regulation (EC) No. 440/2008, B.4, Japanese MAFF 12-Nousan.8187 (2000) and EPA OPPTS 870.2400 (1998).

Method

The test item was applied by topical semi-occlusive application of 0.5 mL to the intact skin of the left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated separately for each animal across 3 scoring times (24, 48 and 72 hours after patch removal) for erythema/eschar grades and for oedema grades, respectively.

Results

The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean erythema/eschar and oedema score for each of the three animals was therefore 0. The test item did not cause any staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin. The test item is considered to be “not irritating” 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 vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 January 2014 to 17 January 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Adequate in vivo testing carried out for US regulation, hence no in vitro study is provided.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 11 weeks
- Weight at study initiation: 1791 - 1967g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Water (e.g. ad libitum): Community tap-water from Itingen ad libitumin water bottles.
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18 ± 3 °C
- Humidity (%):30 - 70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light):12 hours light and 12 hours darkness.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml/animal

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: The eye reactions were assessed according to the numerical scoring system listed in the Commission Regulation (EC) No 440/2008, B.5

TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp. To assess the presence ofcorneal damage, instillation of a 0.5% fluorescein solution was performed directly onto the cornea of both eyesand assessment was performed with a hand slit lamp

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes 1 hour after treatment, such as reddening of the conjunctivae and sclerae, ocular discharge and slight iris light reflex. These effects were reversible and were no longer evident 24 hours after treatment. No abnormal findings were observed in the cornea of any animals at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinicalsigns were observed. Thus, the test item did not induce significant or irreversibledamage to the rabbit eye.
The mean score was calculated separately for each animal across three scoring times (24, 48 and 72 hours after instillation) for corneal opacity, iris light reflex, redness and chemosis of the conjunctivae, respectively. The individual mean scores for corneal opacity and iris light reflex were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00 for reddening and 0.00 for chemosis for all animals, respectively.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item did not cause any damage to the rabbit eye. The individual mean scores for corneal opacity and iris light reflexwere 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00 for reddening and 0.00 for chemosis for all animals. Based on these results, the test item is considered to be “not irritating” to rabbit eye.

Executive summary:

Introduction

The primary eye irritation potential of the test item was investigated according to OECD test guideline no. 405, commission regulation 440/2008/EC, Japanese MAFF (2000) and EPA OPPTS 870.2400 (1998).

Method

The test item was applied by instillation of 0.1 mL into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation.

Results

The instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes 1 hour after treatment, such as reddening of the conjunctivae and sclerae, ocular discharge and slight iris light reflex. These effects were reversible and were no longer evident 24 hours after treatment. No abnormal findings were observed in the cornea of any animals at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the rabbit eye. The mean score was calculated separately for each animal across three scoring times (24, 48 and 72 hours after instillation) for corneal opacity, iris light reflex, redness and chemosis of the conjunctivae, respectively. The individual mean scores for corneal opacity and iris light reflex were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00 for reddening and 0.00 for chemosis for all animals, respectively. Based on these results, the test item is considered to be “not irritating” to rabbit eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

The acute dermal irritation potential of the test item was investigated according to OECD test guideline No. 404, Commission Regulation (EC) No. 440/2008, B.4, Japanese MAFF 12-Nousan.8187 (2000) and EPA OPPTS 870.2400 (1998). The test item was applied by topical semi-occlusive application of 0.5 mLto the intact skin of the left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated separately for each animal across 3 scoring times (24, 48 and 72 hours after patch removal) for erythema/eschar grades and for oedema grades, respectively. The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean erythema/eschar and oedema score for each of the three animals was therefore 0. The test item did not cause any staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin. The test item is considered to be “not irritating” to rabbit skin.

Eye irritation:

The primary eye irritation potential of the test item was investigated according to OECD test guideline no. 405, commission regulation 440/2008/EC, Japanese MAFF (2000) and EPA OPPTS 870.2400 (1998). The test item was applied by instillation of 0.1 mL into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation. The instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes 1 hour after treatment, such as reddening of the conjunctivae and sclerae, ocular discharge and slight iris light reflex. These effects were reversible and were no longer evident 24 hours after treatment. No abnormal findings were observed in the cornea of any animals at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the rabbit eye. The mean score was calculated separately for each animal across three scoring times (24, 48 and 72 hours after instillation) for corneal opacity, iris light reflex, redness and chemosis of the conjunctivae, respectively. The individual mean scores for corneal opacity and iris light reflex were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00 for reddening and 0.00 for chemosis for all animals, respectively. Based on these results, the test item is considered to be “not irritating” to rabbit eye.

Justification for selection of skin irritation / corrosion endpoint:
One study is available. Guideline, GLP study; K=1

Justification for selection of eye irritation endpoint:
One study is available. Guideline, GLP study; K=1

Justification for classification or non-classification

No irritant effects were detected in either skin irritation or eye irritation studies hence classification is not required according to CLP.