Branched and linear octadecanoic acid, esters with glycerol oligomers

Endpoint summary

Description of key information

Skin (similar to OECD 404, RL2): not irritating

Eye (similar to OECD 405, RL2): 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:

30 Oct - 1 Nov 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

/ occlusive dressing used, 24 h exposure period, no experimental 72 h reading performed, evaluation of reversibility of effects not possible due to study termination 3 days after dosing no initial test, individual body weights at conclusion of test missing, no information on test substance

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

28 July 2015

Deviations:

yes

Remarks:

/ occlusive dressing used, 24 h exposure period, no experimental 72 h reading performed, evaluation of reversibility not possible

Qualifier:

equivalent or similar to guideline

Guideline:

other: Japanese Ministry of Health and Welfare

Version / remarks:

not specified

Deviations:

not specified

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no information given
- Age at study initiation: about 3 months
- Weight at study initiation: approximately 2 kg
- Housing: individual in stainless steel cages
- Diet: Lab Diet Certified Rabbit Diet (#5322), 100 g/ day/ animal
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3 - 23.9
- Photoperiod (hrs dark / hrs light): 12/ 12

IN-LIFE DATES: From: 30 Oct To: 1 Nov 2001

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

in addition: abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

24 h

Observation period:

3 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm²
- Type of wrap if used: The test material was introduced to the test site under a square surgical gauze pad (Johnson & Johnson gauze sponge), two single layers thick. The test article and gauze pad were then covered with a piece of Kendall Webril® pad and were then fixed in place with 3 inch of Dermicel® Hypo-allergenic cloth tape (Johnson & Johnson). The entire trunk of each animal was then encased in an impermeable occlusive plastic wrapping, fixed in place with a 3 inch Zonas® porous tape (Johnson & Johnson).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed with water and paper towels.
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
24, 48 and 72 h after dosing (0, 24 and 48 h after patch removal)

SCORING SYSTEM: Draize scoring system
- Method of calculation: No 72 h data are available; for calculation of mean scores, the highest score was considered as 72 h score

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

male

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

other: evaluation not possible, no skin evaluation performed 72 h after patch removal

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

male

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

other: evaluation not possible, no skin evaluation performed 72 h after patch removal

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

female

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

other: evaluation not possible, no skin evaluation performed 72 h after patch removal

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

male

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

male

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

female

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

not fully reversible within: 48 h

Irritant / corrosive response data:

The exposure period of 24 h caused very slight to well defined erythema and very slight to slight edema on rabbit skin. Erythema were not fully reversible within 72 h after dosing, edema, however, were fully reversible within 48 or 72 h after dosing. As the observation period after removing of the patch is limited to 48 h the mean scores for 24, 48 and 72 h were calculated by including the respective highest grade as 72 h value in addition. mean erythema scores (24, 48 and 72 h) were calculated to be 1.0 or 2.0, respectively, and mean edema scores (24, 48 and 72 h) 0 or 0.7, respectively. Although the observation period of 48 h after patch removal is too short to allow a conclusive decision regarding reversibility, it is concluded that the described effects are not sufficient to consider Isooctadecanoic acid, ester with oxybis[propanediol] (CAS 73296-86-3) as irritating to the skin taking into consideration the severity of the effects observed in the individual animals.

Table 1: Results of skin irritation study (for hazard assessment, the results on intact skin are considered)

Observation time	Rabbit no
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
24	1	0	1	0	2	1
48	1	0	1	0	2	0
72	No experimental data available; for calculation of mean scores, the 72 h values were assumed to be equivalent to the highest score determined either at 24 or 48 h reading time point (worst case assumption)

Table 2: Calculation of mean scores (for hazard assessment, the results on intact skin are considered)

	Rabbit no
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
Mean value 24 + 48 + 72 h*	1	0	1	0	2	0.7

*No 72 h data are available: for calculation of mean scores, the 72 h values were assumed to be equivalent to the highest score determined either at 24 or 48 h reading time point (worst case assumption).

Interpretation of results:

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

Conclusions:

CLP: 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:

23 Aug - 26 Aug 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

/ no anaesthetics were used, no initial test using one animal was performed, limited data on test animals given (body weight, age)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

02 Oct 2012

Deviations:

yes

Remarks:

/ no anaesthetics were used, no initial test using one animal was performed, limited data on test animals given (body weight, age)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hare-Marland, Hewitt, New Jersey, USA
- Housing: individual, in cages
- Diet: Purina Lab Rabbit Chow, ad libitum
- Water: tap water, ad libitum, anaysis performed
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/ 12

IN-LIFE DATES: From: 23 Aug To: 26 Aug 1990

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

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 and 3 females

Details on study design:

SCORING SYSTEM: Draize scoring system

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 6 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 6 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:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 3 animals (#2, 4 - 6)

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 4 animals (#1, 2, 5, 6)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 2 animals (#3 - #4)

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

1 h after test substance application all animals showed conjunctival redness scored with grade 1 which was fully reversible at the 24 h reading time point in all animals except two animals. One male showed a worsening at the 24 h reading time point (score 2), which was augmented at 48 h (score 1) and was reversed at 72 h after application. In the other male the conjunctival redness was fully reversible at 48 h. 1 h and 24 h after test substance application dulling of the cornea was observed in two animals. Additionally, moderate ocular discharge was detected at the 1 h reading time point. In addition, chemosis was observed in all animals 1 h after treatment (grade 1 and 2, respectively) which was reversible in all animals except of two at the 24 h reading time point. For these two animals chemosis was reversible within 48 h (mean score (24, 48, 72 h) = 0.3, respectively). Additionally, moderate ocular discharge was detected at the 1 h reading time point. No effects on iris or cornea were observed.

Table 1: Individual scores of eye irritation

	Rabbit #	Time [h]	conjunctivae		iris	cornea
			redness	chemosis
male	1	1	1	1	0	0
		24	1	0	0	0
		48	0	0	0	0
		72	0	0	0	0
		average	0.3	0.0	0.0	0.0
	2	1	1	2	0	0
		24	0	0	0	0
		48	0	0	0	0
		72	0	0	0	0
		average	0.0	0.0	0.0	0.0
	3	1	1	1	0	0
		24	2	1	0	0
		48	1	0	0	0
		72	0	0	0	0
		average	1.0	0.3	0.0	0.0
female	4	1	1	1	0	0
		24	0	1	0	0
		48	0	0	0	0
		72	0	0	0	0
		average	0.0	0.3	0.0	0.0
	5	1	1	2	0	0
		24	0	0	0	0
		48	0	0	0	0
		72	0	0	0	0
		average	0.0	0.0	0.0	0.0
	6	1	1	1	0	0
		24	0	0	0	0
		48	0	0	0	0
		72	0	0	0	0
		average	0.0	0.0	0.0	0.0

For evaluation, scores obtained at the 24, 48 and 72 h reading time points were considered.

Interpretation of results:

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

Conclusions:

CLP: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Irritation

There are in vivo data available regarding skin and eye irritation / corrosion for Polyaldo 2-1-IS (CAS 73296-86-3) in order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.1 and 8.2.

Skin Irritation

CAS 73296-86-3

A primary dermal irritation study was performed with the test substance according to OECD guideline 404 and under GLP conditions (Nitka, 2001) in 3 rabbits (New Zealand White). The clipped trunk skin was exposed to 0.5 mL unchanged test material for 24 hours under occlusive conditions. The rabbits were observed for 3 days. Skin reactions were assessed using the Draize scheme 24, 48 and 72 h after dosing. Thus, experimental readings were performed 0, 24 and 48 h after patch removal. No skin evaluation was performed 72 h after patch removal. The exposure period of 24 h caused very slight to well defined erythema and very slight to slight edema on rabbit skin. Erythema were not fully reversible within 72 h after dosing, edema, however, were fully reversible within 48 or 72 h after dosing. As the observation period after removing of the patch is limited to 48 h after patch removal the mean scores for 24, 48 and 72 h were calculated by including the respective highest grade as 72 h value in addition. Therefore, mean erythema scores (24, 48 and 72 h) were calculated to be 1.0 or 2.0, respectively, and mean edema scores (24, 48 and 72 h) 0 or 0.7, respectively. Although the observation period of 48 h after patch removal is too short to allow a conclusive decision regarding reversibility it is concluded that the described effects are not sufficient to classify Isooctadecanoic acid, ester with oxybis[propanediol] (CAS 73296-86-3) for skin irritation taking into consideration the severity of the effects observed in the individual animals. Isooctadecanoic acid, ester with oxybis[propanediol] (CAS 73296-86-3) is therefore not regarded as skin irritant.

Eye irritation

CAS 73296-86-3

An acute eye irritation study with the test substance was performed according to a protocol similar to OECD guideline 405 and under GLP conditions with 3 male and 3 female New Zealand White rabbits (Mallory, 1990). One eye of the rabbits was exposed to 0.1 mL of the undiluted test substance and scored for eye reactions. The untreated eye served as control. The animals were observed for 72 h and scoring was performed 1, 24, 48 and 72 h after application. 1 h after test substance application all animals showed conjunctival redness scored with grade 1 which was fully reversible at the 24 h reading time point in all animals except of two. One male showed a worsening at the 24 h reading time point (grade 2), which was augmented at 48 h (grade 1) and was reversed at 72 h after application (mean score (24, 48, 72 h) = 1.0). In the other male animal the conjunctival redness was fully reversible at 48 h (mean score (24, 48, 72 h) = 0.3). In addition, chemosis was observed in all animals 1 h after treatment (grade 1 and 2, respectively) which was reversible in all animals except of two at the 24 h reading time point. For these two animals chemosis was reversible within 48 h (mean score (24, 48, 72 h) = 0.3, respectively). 1 h and 24 h after test substance application dulling of the cornea was observed in two animals. Additionally, moderate ocular discharge was detected at the 1 h reading time point. No effects on iris or cornea were observed. Based on these results Isooctadecanoic acid, ester with oxybis[propanediol] (CAS 73296-86-3) is not regarded as eye irritant.

Justification for classification or non-classification

The available data on skin irritation / corrosion with Polyaldo 2-1-IS (CAS 73296-86-3) do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.

The available data on eye irritation / corrosion with Polyaldo 2-1-IS (CAS 73296-86-3) do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.