1,3-Propanediol, 2-methyl-, reaction products with ethenyltrimethoxysilane

Endpoint summary

Description of key information

Skin irritation (OECD 404): not irritating
Eye irritation (OECD 405): 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:

14 - 26 Apr 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: 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: Charles River Laboratories France, L’Arbresle, France and Charles River Deutschland GmbH, Kisslegg, Germany
- Age at study initiation: 20 weeks (male) and 10-13 weeks (females)
- Weight at study initiation: 3815 g (male) and 2290-2314 g (females)
- Housing: animals were housed individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet: pelleted standard Kliba Nafag 3418 rodent maintenance diet (batch no. 05/10, Provimi Kliba AG, Kaiseraugst, Switzerland), ad libitum. A piece of wood (batch no. 102240, ABEDD® - LAB & VET GmbH, Vienna, Austria) and a haystick 4642 (batch no. 54/09, Provimi Kliba AG, Kaiseraugst, Switzerland) were also provided for each animal.
- Water: community tap water from Füllinsdorf, Switzerland, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20 Apr 2010 (one female) or 21 Apr 2010 (the male and the second female) To: 26 Apr 2010

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

6 (one male and one female) or 7 days (one female)
Reading time points: 1, 24, 48 and 72 h

Number of animals:

1 male and 2 females

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on the left flank
- Type of wrap if used: the test substance was placed on a surgical gauze patch, which was held in contact with the skin by means of an adhesive hypoallergenic aerated semiocclusive dressing and a restrainer bandage wrapped around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: the skin was flushed with lukewarm tap water.
- Time after start of exposure: 4 h

SCORING SYSTEM: according to the numerical scoring system listed in the Commission Regulation (EC) No. 440/2008, B.4, Draize scoring system

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

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 time points. The individual mean erythema/eschar and edema score for each of the three animals was therefore 0. No staining and no corrosive effects were observed on the treated skin.

Other effects:

No further local or systemic effects were observed.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of an in vivo study, performed according to OECD/EC guidelines, Y-15866 is concluded not to have adverse effects on the skin.

Executive summary:

The skin irritation potential of Y-15866 was investigated in a GLP-conform study according to OECD guideline 404. The undiluted test substance (0.5 mL) was applied for 4 h to the clipped skin of 3 young adult New Zealand White rabbits (1 male and 2 females) under semiocclusive conditions. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation time points. No signs of systemic toxicity were seen. The mean erythema and edema scores over 24, 48 and 72 h were 0 for all 3 animals.

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:

26 Apr - 07 May 2010

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

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: 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: Charles River Laboratories France, L’Arbresle, France and Charles River Deutschland GmbH, Kisslegg, Germany
- Age at study initiation: 22 weeks (male) and 12-15 weeks (females)
- Weight at study initiation: 4025 g (male) and 2618-2680 g (females)
- Housing: animals were housed individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet: pelleted standard Kliba Nafag 3418 rodent maintenance diet (batch no. 05/10, Provimi Kliba AG, Kaiseraugst, Switzerland), ad libitum. A piece of wood (batch no. 102240, ABEDD® - LAB & VET GmbH, Vienna, Austria) and a haystick 4642 (batch no. 54/09, Provimi Kliba AG, Kaiseraugst, Switzerland) were also provided for each animal.
- Water: community tap water from Füllinsdorf, Switzerland, ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 03 May 2010 (one female) or 04 May 2010 (the male and the second female) To: 07 May 2010

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

5 (one male and one female) or 6 days (one female)
reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

1 male and 2 females

Details on study design:

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

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 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:

other: mean after 24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean after 24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Slight reddening of the conjunctivae was noted in all animals 1 h after instillation and persisted in one female at the 24 h reading. Slight reddening of the sclerae was noted in the male and one female at the 1 h reading. At the same observation point, slight swelling of the conjunctivae was also present in this female. No abnormal findings were observed in the cornea or for the iris light reflex. No corrosion and no staining were observed in the treated eyes.

Other effects:

No further local or systemic effects were observed.

Table 1. Results of eye irritation study (individual scores)

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	chemosis
1	1	1	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0
2	1	1	1	0	0
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0.33	0	0	0
3	1	1	0	0	0
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	average	0	0	0	0

 

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of an in vivo study, performed according to OECD/EC guidelines, Y-15866 is concluded not to have adverse effects on the eye.

Executive summary:

The eye irritation potential of Y-15866 was investigated in a study according to OECD guideline 405 and in compliance with GLP. The undiluted test substance (0.1 mL) was placed into the conjunctival sac of the left eye of 3 young adult New Zealand White rabbits (1 male and 2 females). Scoring of irritation effects was performed approximately 1, 24, 48 and 72 h after test substance instillation. The instillation of Y-15866 into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, as well as chemosis. These effects were reversible and were no longer evident up to 48 h after treatment. No abnormal findings were observed in the cornea or for the iris light reflex of any animals at any of the examinations. No corrosion and no staining of the treated eyes and no clinical signs were observed. The individual mean scores after 24, 48 and 72 h for corneal opacity and iris light reflex were 0 for all three animals. The individual mean scores after 24, 48 and 72 h for the conjunctivae were 0, 0.33 and 0 for reddening, respectively, and 0 for chemosis for all 3 animals.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation

The skin irritation potential of Y-15866 was investigated in a GLP-conform study according to OECD guideline 404 (Arcelin, 2011). The undiluted test substance (0.5 mL) was applied for 4 h to the clipped skin of 3 young adult New Zealand White rabbits (1 male and 2 females) under semiocclusive conditions. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation time points. No signs of systemic toxicity were seen. The mean erythema and edema scores after 24, 48 and 72 h were 0 for all 3 animals.

Eye irritation

The eye irritation potential of Y-15866 was investigated in a study according to OECD guideline 405 and in compliance with GLP (Arcelin, 2010). The undiluted test substance (0.1 mL) was placed into the conjunctival sac of the left eye of 3 young adult New Zealand White rabbits (1 male and 2 females). Scoring of irritation effects was performed approximately 1, 24, 48 and 72 h after test substance instillation. The instillation of Y-15866 into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, as well as chemosis. These effects were reversible and were no longer evident up to 48 h after treatment. No abnormal findings were observed in the cornea or for the iris light reflex of any animal at any of the examinations. No corrosion and no staining of the treated eyes and no clinical signs were observed. The individual mean scores for corneal opacity and iris light reflex after 24, 48 and 72 h were 0 for all three animals. The individual mean scores after 24, 48 and 72 h for the conjunctivae were 0, 0.33 and 0 for reddening, respectively, and 0 for chemosis for all 3 animals.

Justification for classification or non-classification

The available data on skin and eye irritation of Y-15866 do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.