Hydrogenated rosin alcohols

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted at a GLP facility and according to OECD guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

Hydrogenated rosin alcohols

EC Number:

701-057-0

Cas Number:

2156595-41-2

IUPAC Name:

Hydrogenated rosin alcohols

Test material form:

liquid: viscous

Details on test material:

Sponsor's identification: Technical Hydroabietyl Alcohol
Description: Light amber coloured extremely viscous liquid
Lot number: HR-078
Purity: 100% (UVCB)
Expiry date: 21 December 2012
Storage conditions: Room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Two New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan Laboratories UK Ltd., Leicestershire, UK. At the start of the study the animals weighed 2.36 or 2.53 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label. The animals were individually housed in suspended cages. Free access to mains drinking water and food (2930C Teklad Global Certified Rabbit diet supplied by Harlan
Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.Two New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan
Laboratories UK Ltd., Leicestershire, UK. At the start of the study the animals weighed 2.36 or 2.53 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label. The animals were individually housed in suspended cages. Free access to mains
drinking water and food (2930C Teklad Global Certified Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

2

Details on study design:

On the day before the test each of a group of two rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study. On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 ml of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period. Four hours after application the corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits.
Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale:

Erythema and Eschar Formation Value
No erythema..................................................................................................... 0
Very slight erythema (barely perceptible).................................................... 1
Well-defined erythema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Moderate to severe erythema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Severe erythema (beef redness) to eschar formation
preventing grading of erythema....... ......................................................... 4


Oedema Formation
No oedema... .................................................................................................... 0
Very slight oedema (barely perceptible)...................................................... 1
Slight oedema (edges of area well-defined by definite raising). ............ 2
Moderate oedema (raised approximately 1 millimetre)............................. 3
Severe oedema (raised more than 1 millimetre and
extending beyond the area of exposure)..................................................... 4

Any other skin reactions and clinical signs of toxicity, if present, were also recorded. Individual bodyweights were recorded on Day 0 (the day of dosing) and at the end of the observation period.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 1 hour

Score:

0.8

Max. score:

3

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Reversibility:

not specified

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Reversibility:

not specified

Any other information on results incl. tables

Individual Skin Reactions
Skin Reaction	Observation Time (following patch removal)	Individual Scores- Rabbit Number and Sex		Total
		72236 Male	72237 Male
Erythema/Eschar Formation	Immediately 1 Hour 24 Hours 48 Hours 72 Hours	2 1 1 1 0	2 2 1 1 0	( 2 ) ( 3 ) 2 ( 2 ) 0
Oedema Formation	Immediately 1 Hour 24 Hours 48 Hours 72 Hours	1 1 0 0 0	2 1 1 0 0	( 3 )  ( 2 ) 1 ( 0 ) 0
Sum of 24 and 72-Hour Readings (S)                   3
Primary Irritation Index (S/4)                                  3/4=0.8
Classification                                                       MILD IRRITANT

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test item produced a primary irritation index of 0.8 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit. A single 4-Hour, semi-occluded application of the test item to the intact skin of two rabbits produced well-defined erythema and very slight to slight oedema. Both treated skin sites appeared normal at the 72-Hour observation. The test item produced a primary irritation index of 0.8 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.