2,6,10,15,19,23-hexamethyltetracosane

Endpoint summary

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:

2010

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Duration of treatment / exposure:

4h exposure

Observation period:

After removal of wrappings : observation at 30min, 24h, 48h and 72h

Number of animals:

3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0.22

Max. score:

0.33

Reversibility:

fully reversible

Remarks:

no effect after 72h

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

ca. 0.33

Max. score:

1

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

ca. 0.33

Max. score:

1

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Detail on results :

Rabbit	H3711	H3712	H3713	MEAN SCORES
Sex	M	M	M
Pretest body weight (kg)	2.6	2.6	2.8
Terminal body weight (kg)	2.7	2.7	2.8
Time after patch removal	Erythema & Eschar formation
60min	1	1	1
24h	0	0	1	0.33
48h	0	0	1	0.33
72h	0	0	0	0
Time after patch removal	Edema
60min	1	0	0
24h	0	0	0	0
48h	0	0	0	0
72h	0	0	0	0
Sum of mean scores				0.66
Primary Irritation Index (PII) (=Sum of mean scores/3)				0.22

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to EEC, squalane is not considered irritating to the skin.

Executive summary:

In vivo irritant or corrosive effects of squalan were determined using EPA OPPTS 870.2500 guideline. The test item was applied on rabbit skin during 4h. The test sites were scored for dermal irritation at 60min after removal of wrappings and scored again at 24, 48 and 72h. The modified Primary Irritating Index is 0.22.

In conclusion, in this study, the squalan is considered non-irritant.

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:

2010

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Duration of treatment / exposure:

72 hrs

Observation period (in vivo):

1, 24, 48 and 72 hrs

Number of animals or in vitro replicates:

3

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1 hr

Score:

ca. 6.67

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

24 h

Score:

ca. 5.33

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

48 h

Score:

ca. 0.67

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

72 h

Score:

ca. 0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 2

Max. score:

2

Results :

Table 1 : Individual score of ocular reactions

Animal n°	Time (hrs)	Score of ocular reactions
		Cornea		Iris	Conjuntivae
		Opacity	Area		Redness	Chemosis	Discharge
1	1	0	0	0	2	0	2
	24	0	0	0	2	0	1
	48	0	0	0	0	0	0
	72	0	0	0	0	0	0
2	1	0	0	0	2	0	1
	24	0	0	0	1	0	0
	48	0	0	0	0	0	0
	72	0	0	0	0	0	0
3	1	0	0	0	2	0	1
	24	0	0	0	2	0	2
	48	0	0	0	1	0	0
	72	0	0	0	0	0	0

Mean total scores :

- 1hr : 6.67

- 24hrs : 5.33

- 48hrs : 0.67

- 72hrs : 0

Classification according to EEC criteria

	Animal 1			Animal 2			Animal 3			EEC Index
	24 hrs	48 hrs	72 hrs	24 hrs	48 hrs	72 hrs	24 hrs	48 hrs	72 hrs
Cornea opacity	0	0	0	0	0	0	0	0	0	0
Iris lesions	0	0	0	0	0	0	0	0	0	0
Conjunctival redness	2	0	0	1	0	0	2	1	0	2
Conjunctival chemosis	0	0	0	0	0	0	0	0	0	0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to OPPTS, ocular administration of squalan is not an ocular irritant.
According to EEC, squalane does not require a risk phrase.

Executive summary:

The aim of the study is to determine the irritant and/or corrosive effects if any, of a test article when instilled ibnto the rabbit eye. This study was designed to comply with the standards set forth in EPA Health Effects testing Guidelines, OPPTS Series 870.2400, final guideline, august 2008.

Three healthy New Zealand White rabbits, free from evidence of ocular irritation and corneal abnormalities, were dosed with squalane. The test article (0.1 ml) was placed into the conjunctival sac of one eye of each rabbit. The contralateral eye served as a control. The eyes were examined and scored by the Draize technique at 1, 24, 48 and 72hrs. Sodium fluoresecein dye procedures were used at 24hrs observation interval. The control eyes were observed at the same time periods. Observations for mortality, toxicity and pharmacological effects were recorded at each ocular observation period. Body weights were recorded pretest. The mean total scores were calculated by adding the total score for each time period and dividing by the number of animals.

There was no corneal opacity or iritis noted in any observation period. Conjunctival irritation, noted in 3/3 eyes, cleared within 72hrs.

The control eyes appeared normal at all periods.

There were no abnormal physical signs noted during the observation period.

According to OPPTS, ocular administration of squalane is not an ocular irritant.

According to EEC, squalane does not require risk phrases.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation : In vivo irritant and corrosive effects of squalan were determined using EPA OPPTS 870.2500 guideline. In this study, the squalan is considered non-irritant.

Eyes irritation : the irritant and corrosive effects were determined using EPA OPPTS Series 870.2400 guideline. According to OPPTS and EEC, ocular administration of squalane is not an ocular irritant

Justification for selection of skin irritation / corrosion endpoint:

Recent study according OECD guideline and reliable without restriction

Justification for selection of eye irritation endpoint:

Recent study according OECD guideline and reliable without restriction

Justification for classification or non-classification

Skin irritation :In vivo irritant effects of squalan were determined using EPA OPPTS 870.2500 guideline. In this study, the squalan is considered non-irritant.

Eyes irritation :the irritant effects were determined using EPAOPPTS Series 870.2400 guideline.According to OPPTS and EEC, ocular administration of squalane is not an ocular irritant