Isooctadecyl pivalate

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:

8 - 16 Mar 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. Few details on animal husbandry were given and the analytical purity was not stated.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted Apr 2002

Deviations:

yes

Remarks:

few details on animal husbandry given, analytical purity not stated

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.390 kg (no further details given)

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

other: not required, untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

7 d
Reading time points: 1, 24, 48 and 72 h, and 4, 5, 6 and 7 days

Number of animals:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed with absorbant paper moistened with distilled water
- 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:

1.33

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Slight or well-defined erythema (score 1 or 2) was observed in 3/3 animals from 1 h post-application. At the 24 h reading time point, 2/3 animals had well-defined (score 2) and 1/3 slight erythema (score 1). Slight eythema persisted in 2/3 rabbits until Day 5 and in 1/3 until Day 4. At the 1-hour reading time point 1/3 animals had slight edema (score 2) and 1/3 animals had very slight edema (score 1). In both animals very slight edema (score 1) was noted at the 24-hour reading time point, while the effect had cleared within 48 hours. The erythema and edema had cleared completely by the 6 day-reading time point. One rabbit had dry skin from Day 2 - 7, while another rabbit had dry skin from Day 4 - 7.

Table 1: individual skin irritation scores

Observation time	Rabbit No.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	1	2	1	0	2	1
24 h	2	1	1	0	2	1
48 h	1	0	1	0	1	0
72 h	1	0	1	0	1	0
4 days	1	0	1	0	1	0
5 days	1	0	0	0	1	0
6 days	0	0	0	0	0	0
7 days	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	1.33	0.33	1.00	0	1.33	0.33

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:

4 - 11 Apr 1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given

Principles of method if other than guideline:

Draize Testing method (Draize, J.H. et al., J. Pharm. Exp. Ther. 82: 377-390, 1944) as prescribed by the FDA (in The Federal Register 38 No.187 §15000.42, USA)

GLP compliance:

no

Species:

rabbit

Strain:

other: albino

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

7 days
Reading time points: at least 24, 48 and 72 h and 7 days (not further specified in the study report)

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: 2% fluorescein, slit lamp

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:

mean

Remarks:

of 3 animals

Time point:

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:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: The chemosis score was included in an overall score for conjunctival erythema and swelling

Irritant / corrosive response data:

The scores for eye irritation effects (cornea, iris and conjunctival erythema and chemosis) were 0 at all reading time points in 3/3 rabbits.

Other effects:

No effects on behavioural patterns or food intake were observed.

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

Skin irritation 

CAS 58958-60-4

A skin irritation study was performed with Isooctadecyl pivalate according to a protocol similar to OECD guideline 404 (Evic-Ceba, 1993). The shaved skin of 3 male New Zealand White rabbits was exposed to 0.5 mL undiluted test material for 24 hours under semiocclusive conditions. The skin irritation effects were evaluated 1, 24, 48 and 72 hours, and 4, 5, 6 and 7 days after patch removal. Slight or well-defined erythema (score 1 or 2) was observed in 3/3 animals from 1 h post-application. At the 24-h reading time point, 2/3 animals had well-defined and had 1/3 slight erythema. Slight eythema persisted in 1/3 rabbits until Day 4 and in 2/3 until Day 5. At the 1-hour reading time point 1/3 animals had slight edema (score 2) and 1/3 animals had very slight edema (score 1). In both animals very slight edema was noted at the 24-hour reading time point, while the effect had cleared within 48 hours. The erythema and edema had cleared completely by the 6-day reading time point. The mean erythema scores (over 24, 48 and 72 hours) per animal were 1.33, 1.0 and 1.33, respectively. The mean edema scores (over 24, 48 and 72 hours) per animal were 0.33, 0 and 0.33, respectively. The test substance is not considered to be irritating to the skin.

Eye irritation 

CAS 58958-60-4

An acute eye irritation study was performed with Isooctadecyl pivalate, according to the Draize Testing method (Draize, J.H. et al., J. Pharm. Exp. Ther. 82: 377-390, 1944) and as prescribed by the FDA (The Federal Register 38 No.187 §15000.42, USA) (BTL, 1972). 0.1 mL of the test substance was instilled into the eyes of 3 albino rabbits. The animals were observed for 7 days and scoring was performed at least at least 24, 48 and 72 h and 7 days after instillation (the reading time points were not further specified in the study report). The chemosis score was included in an overall score for conjunctival erythema and swelling, which was according to the method specified above. The scores for eye irritation effects (cornea, iris and conjunctival erythema and chemosis) were 0 at all reading time points in 3/3 rabbits. The test substance is not considered to be 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.