3,5-dimethylhex-1-yn-3-ol

Endpoint summary

Description of key information

Primary Skin Irritation Score:  1.5
The subject material is a primary ocular irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Methyl pentynol is a structural analogon to the to be registered substance. Justification for read across is perfectly provided in the document "Screening-Level Hazard Characterization and Prioritization Document on ALPHA HYDROXY ALKYNES CLUSTER - 4 Chemicals" prepared by EPA in 2009. This document is attached at this endpoint of this dossier.

Qualifier:

equivalent or similar to guideline

Guideline:

other: Section 1500.41, - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, P. 27019, 27 September 1973.

Deviations:

not specified

Principles of method if other than guideline:

In carrying out the study the experimental sample was used as supplied. A group o f six albino rabbits were clipped over a wide area. One side o f the animals' backs was abraded at one site with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding.
The skin of the other side was allowed to remain intact. A 0.5 ml portion of material was applied to an abraded and an intact skin site on the same rabbit.
Gauze patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the animals to hold the patches in place.
The wrapping was removed at the end o f the twenty-four hour period and the treated areas were examined. Readings were also made after seventy-two hours. The Draize method of scoring was employed.

GLP compliance:

no

Species:

rabbit

Strain:

other: albino

Type of coverage:

semiocclusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6 rabbits

		Reading (Hours)	Rabbit Number
	Erythema and Eschar Formation		1	2	3	4	5	6	Average
	Intact Skin	24	1	1	1	1	1	1	1.0
	Intact Skin	72	1	1	1	1	1	1	1.0
	Abraded Skin	24	1	1	1	1	1	1	1.0
	Abraded Skin	72	1	1	1	1	1	1	1.0
			Subtotal						4.0
		Reading (Hours)	Rabbit Number
	Edema Formation		1	2	3	4	5	6	Average
	Intact Skin	24	1	1	1	1	1	1	1.0
	Intact Skin	72	0	0	0	0	0	0	0.0
	Abraded Skin	24	1	1	1	1	1	1	1.0
	Abraded Skin	72	0	0	0	0	0	0	0.0
			Subtotal						2.0
			Total						6.0

Primary Irritation Score:

6.0 / 4 = 1.5

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: Section 1500.41, - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, P. 27019, 27 September 1973.

Conclusions:

Based on the accompanying table, the subject material would not be classified as a primary irritant to albino rabbits within the definition of the Act-Reference: Section 1500.3 (c) (4) and requires no cautionary labeling with respect to that section.
Primary Irritation Score:
6.0 / 4 = 1.5

Executive summary:

Based on the accompanying table, the subject material would not be classified as a primary irritant to albino rabbits within the definition of the Act-Reference: Section 1500.3 (c) (4) and requires no cautionary labeling with respect to that section.

Primary Irritation Score:

6.0 / 4 = 1.5

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Methyl pentynol is a structural analogon to the to be registered substance. Justification for read across is perfectly provided in the document "Screening-Level Hazard Characterization and Prioritization Document on ALPHA HYDROXY ALKYNES CLUSTER - 4 Chemicals" prepared by EPA in 2009. This document is attached at this endpoint of this dossier.

Qualifier:

according to guideline

Guideline:

other: Section 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol . 38, No. 187, P. 27019, 27 September 1973

GLP compliance:

no

Species:

rabbit

Strain:

other: albino

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6 animals

		Hours After Application												Days After Application
		1			24						72			5			7
Rabbit Number		Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae	Cornea	Iris	Conjunctivae
1		40	10	20	40	10	20	40	10	20	40	10	20	40	10	20	40	10	16
2		40	10	20	40	10	20	40	10	16	40	10	16	40	10	14	40	10	12
3		40	10	20	40	10	20	40	10	20	40	10	20	40	10	20	40	10	18
4		40	10	20	40	10	20	40	10	12	40	10	12	40	10	10	40	10	10
5		40	10	20	40	10	20	40	10	20	40	10	20	40	10	20	40	10	20
6		40	10	20	40	10	20	40	10	18	40	10	16	40	10	16	40	10	16

Interpretation of results:

other: primary ocular irritant

Remarks:

Criteria used for interpretation of results: other: Section 1500.42 (b) (1) (2) P. 27019 - "Illustrated Guide for Grading Eye Irritation By Hazardous Substances"

Conclusions:

The subject material is a primary ocular irritant within the definition of the Act-Reference:
Section 1500.42 (b) (1) (2) P. 27019 and requires cautionary labeling with respect to that section.

Executive summary:

The subject material is a primary ocular irritant within the definition of the Act-Reference:

Section 1500.42 (b) (1) (2) P. 27019 and requires cautionary labeling with respect to that section.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
No study availabe on the substance as such, but a study on a surrogate is available: Methyl pentynol is a structural analogon to the to be registered substance. Justification for read across is perfectly provided in the document "Screening-Level Hazard Characterization and Prioritization Document on ALPHA HYDROXY ALKYNES CLUSTER - 4 Chemicals" prepared by EPA in 2009. This document is attached at the corresponding endpoint of this dossier.

Justification for selection of eye irritation endpoint:
No study availabe on the substance as such, but a study on a surrogate is available: Methyl pentynol is a structural analogon to the to be registered substance. Justification for read across is perfectly provided in the document "Screening-Level Hazard Characterization and Prioritization Document on ALPHA HYDROXY ALKYNES CLUSTER - 4 Chemicals" prepared by EPA in 2009. This document is attached at the corresponding endpoint of this dossier.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.2 and Chapter 3.3 it is classified to be (severe) irritating to eye and (mild) skin irritant.