2,4,6-tri-sec-butylphenol

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Duration of treatment / exposure:

Single application

Observation period:

14 days

Number of animals:

3

Irritation parameter:

erythema score

Basis:

animal: observations in three animals

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Irritation parameter:

edema score

Basis:

animal: observations in three animals

Time point:

24/48/72 h

Score:

0.57

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Table: Skin irritation scores
Observation Time	Erythema			Oedema
	Animal 1	Animal 2	Animal 3	Animal 1	Animal 2	Animal 3
1h	2	0	1	1	0	1
24h	2	2	1	0	1	1
48h	2	2	0	0	1	0
72h	3	3	0	2	0	0
7 day	4	2	-	0	0	-
14 day	0	0	-	0	0	-
Mean of 24/48/72h	2.3	2.3	0.3	0.7	0.7	0.3

Table: Observations of treated area
Observation Time	Animal 1			Animal 2			Animal 3
	Discoloration	Dry/ Rough/ Chapped	Scaling/ Desquamation/ New skin	Discoloration	Dry/ Rough/ Chapped	Scaling/ Desquamation/ New skin	Discoloration	Dry/ Rough/ Chapped	Scaling/ Desquamation/ New skin
1h
2 day					x
3 day					x
7 day		x	x	x	x	x
14 day			x		x

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The registration substance was investigated for its skin irritaiton property according to OECD 404. It was found to be irritating to skin.

Executive summary:

The registration substance was investigated for its skin irritaiton property according to OECD 404.

Among the three rabbits treated, two rabbits exhibited erythema of mean score of 2.3 for 24,48, and 72 hours reading and exhibited discoloration, dryness and scaling at reading time 7 and 14 day. The registration substance was found to be irritating to skin.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1mL

Duration of treatment / exposure:

single application

Observation period (in vivo):

up to 72 hours if no effect at reading time 72 hours; up to 7 days if no effect at reading time 7 day; up to 14 days if still effect present at reading time 7 day.

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.44

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48hours

Remarks on result:

no indication of irritation

Eye Irritation Score
Reading time	Animal	Opacity	Iris	Conjunctivae
				Redness	Chemosis
1h	1	0	0	2	2
	2	0	0	1	2
	3	0	0	2	3
24 hours	1	0	0	1	1
	2	0	0	2	1
	3	0	0	1	1
48 hours	1	0	0	0	0
	2	0	0	0	0
	3	0	0	0	0
72 hours	1	0	0	0	0
	2	0	0	0	0
	3	0	0	0	0

Interpretation of results:

GHS criteria not met

Conclusions:

The registration substance is not irritating according to the results obtained in the OECD 405 study.

Executive summary:

The registration substance was investigated for its eye irritation property according to the OECD 405. Schwelling and redening of conjunctivae was observed only at reading time of 24 hours. No classification is warranted.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

The registration substance was investigated for its skin irritaiton property according to OECD 404. It was found to be irritating to skin.

The registration substance was investigated for its eye irritaiton property according to OECD 405. It was found to be not irritating to eye.

Based on GHS criteria, it should be classified as skin irritant, Category 2.