Glycerides, C18-36

Endpoint summary

Description of key information

Skin, rabbit (OECD 404): not irritating

Eye, rabbit (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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

(Limited details on materials and methods, and results, no test substance volume.)

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted Jul 2015

Deviations:

yes

Remarks:

Limited details on materials and methods, and results; no test substance volume.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not required

Observation period:

72 h

Number of animals:

3 (sex not specified)

Details on study design:

OBSERVATION TIME POINTS
1, 24, 48 and 72 h

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

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:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 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:

3/3 animals showed mild erythema (score 1) at the 1-h reading time point, which persisted in 1/3 animals until the 24-h reading time point. All effects had cleared within 48 h after patch removal. No oedema was observed in any animal at any time point.

Interpretation of results:

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

Conclusions:

The test substance volume was not stated in the study report. However, the study report states that the test was performed according to OECD guideline 404, which specifies that a volume of 0.5 mL should be used. The result of the study is therefore considered to be acceptable.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

(Limited details on materials and methods, no anaesthetics were used, unknown test substance volume.)

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adpoted Oct 2012

Deviations:

yes

Remarks:

Limited details on materials and methods, test substance volume, no anaesthetics were used.

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Observation period (in vivo):

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

Number of animals or in vitro replicates:

3 (sex not specified)

Details on study design:

SCORING SYSTEM: Draize scoring system

Irritation parameter:

cornea opacity score

Basis:

other: mean of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

other: mean 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:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

other: mean of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

At the 1-h reading time point, 3/3 rabbits exhibited moderate to severe conjunctivae (score 2-3). 3/3 animals had mild-moderate conjunctivae (score 1-2) at the 24-h reading time point (the score was reduced in 2/3 animals at this time point). The conjunctivae persisted in 1/3 animals until 48 h after treatment, while the effect had cleared in the remaining 2/3 animals. All signs of conjunctivae were reversed within 72 h after treatment. 2/3 animals showed chemosis at the 1-h reading time point; the chemosis had cleared completely within 24 h after treatment. No effects were repoted on the cornea or iris in any animal at any reading time point.

Table 1. Individual eye irritation scores

Rabbit #	Time	conjunctivae		iris	cornea
		redness	swelling
1	1 h	2	0	0	0
	24 h	2	0	0	0
	48 h	1	0	0	0
	72 h	0	0	0	0
	Average*	1.0	0.0	0.0	0.0
2	1 h	2	1	1	0
	24 h	1	0	0	0
	48 h	0	0	0	0
	72 h	0	0	0	0
	Average*	0.33	0.0	0.0	0.0
3	1 h	3	1	0	0
	24 h	2	0	0	0
	48 h	0	0	0	0
	72 h	0	0	0	0
	Average*	0.67	0.0	0.0	0.0

*(24h+48h+72h)/3

 

 

Interpretation of results:

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

Conclusions:

The test substance volume was not stated in the study report. However, the study report states that the test was performed according to OECD guideline 405, which specifies that a volume of 0.1 mL should be used. The result of the study is therefore considered to be acceptable.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

A study assessing the skin irritation potential of Dub TGI 24 was performed according to a protocol similar to OECD guideline 404 (please refer to IUCLID section 7.3.1). An unknown volume of the test substance was applied for 4 hrs to the skin of 3 New Zealand White rabbits under semiocclusive conditions. The untreated skin site of the animals served as the control. The skin reactions (erythema and oedema) were scored 1, 24, 48 and 72 hrs after patch removal. 3/3 animals showed mild erythema (score 1) at the 1-hr reading time point, which persisted in 1/3 animals until the 24-hrs reading time point. All effects were reversible within 48 hrs after patch removal. No oedema was observed in any animal at any time point. The individual mean erythema scores over the 24, 48 and 72 hors reading time points were 0, 0.33 and 0, and the edema scores were 0, 0 and 0, respectively. In conclusion, the test substance is considered to be non-irritating to the skin.

Eye irritation

An eye irritation study was performed with Dub TGI 24 similar to OECD guideline 405 (please refer to IUCLID section 7.3.2). The undiluted test substance was instilled into one eye of 3 New Zealand White rabbits. The other eye remained untreated and served as the control. Examination and scoring of effects on the eyes was performed at intervals of 1, 24, 48 and 72 hrs after test substance application. At the 1-hr reading time point, 3/3 rabbits exhibited moderate to severe conjunctivae (score 2-3). 3/3 animals had mild-moderate conjunctivae (score 1-2) at the 24-h reading time point, (the score was reduced in 2/3 animals). The conjunctivae persisted in 1/3 animals until 48 hrs after treatment, while the effect had cleared in the remaining 2/3 animals. All signs of conjunctivae were reversed within 72 hrs after treatment. 2/3 animals showed chemosis at the 1-hr reading time point; the chemosis had cleared completely within 24 hrs after treatment. No effects were reported on the cornea or iris in any animal at any reading time point. The mean chemosis, cornea and iris scores over 24, 48, and 72 hrs were 0 for all 3 animals, respectively. The mean score for conjunctivae over 24, 48, and 72 hrs was 1.0, 0.33 and 0.67 for the 3 animals.In conclusion, the test substance was not considered irritating to the eye.

Justification for classification or non-classification

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