Hydrocarbons, C16-C18, isoalkanes, <2% aromatics

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

No guideline and GLP were followed. No test substance analytical certificate available. Study conducted according to acceptable scientific conditions. Number of tested animals, applied dose, used patch, observation time and observed parameters are acceptable. Exposure time longer than requested by current OECD guideline 404.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

No guideline and GLP were followed. No test substance analytical certificate available. Study conducted according to acceptable scientific conditions. Number of tested animals, applied dose, used patch, observation time and observed parameters are acceptable. Exposure time longer than requested by current OECD guideline 404.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 72h (no 48h scoring)

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 72h ( no 48h scoring)

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Mean 24, 48, and 72 hour scores not specified

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Mean 24, 48, and 72 hour scores not specified

Irritant / corrosive response data:

See below Table 7.3.1/1

Other effects:

No systemic effect was observed following exposure to BP Solvent IH/Isohexadecan. Behavior, general state, fur, food consumption and body weight development were normal.

Table 7.3.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
24 h	0/1/1	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 72h	0-0-0	0-0-0
Reversibility*	c	-
Average time (unit) for reversion	72h	-

* Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, BP solvent IH/Isohexadecane is not classified as skin irritant according to the criteria of annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.

Executive summary:

This data is being read across from the source study that tested Isohexadecane based on analogue read across.

The skin irritating properties of the substance BP solvent IH/isohexadecane was assessed in White Vienna rabbits (3 animals of both sexes). The test substance was applied on a wipe put in contact with the shaved skin under semi-occlusive dressing for 24 hours. At the end of exposure, skin reactions were recorded both at 24 hours (patch removal) and 48 hours after the end of exposure (i.e. 72 -hour time observation) according to the Draize scale. Complete observation time was 14 days.

Moreover, the behavior, general state and food consumption were also observed. Body weight was measured every day. There was a very slight erythema (score 1) in two rabbits at patch removal (observation time = 24h). At the 72-hour observation, no erythema was observed in all 6 animals. No oedema was noted in any animal at any observation time.

No systemic effect was observed following exposure to BP Solvent IH/Isohexadecan. Behavior, general state, fur, food consumption and body weight development were normal.

Under these test conditions, the substance BP solvent IH/Isohexadecan is not classified as a skin irritant according to annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: § 1500.41 Federal Register Vol. 38, No. 187, of the 27 September 1973, page 27019

Principles of method if other than guideline:

Guideline study

GLP compliance:

not specified

Remarks:

study conducted before GLP principles

Test material

Test material information

Constituent 1

Reference substance name:

2,2,4,4,6,8,8-heptamethylnonane

EC Number:

224-506-8

EC Name:

2,2,4,4,6,8,8-heptamethylnonane

Cas Number:

4390-04-9

Molecular formula:

C16H34

IUPAC Name:

2,2,4,4,6,8,8-heptamethylnonane

Details on test material:

- Name of test material (as cited in study report): BP Solvent IH/Isohexadecan
- Substance type: petroleum product, UVCB
- Analytical purity : 100% commercial product

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: between 2.3 and 2.8 kg
- Housing: no data
- Diet (e.g. ad libitum): artificial prepared KF-G 774 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 60 ± 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 150 Lux, 12 h light/12 h dark

IN-LIFE DATES: July 1980

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

24 h

Observation period:

48h after patch was removed (= 72 h after substance application)

Number of animals:

3 males + 3 females

Details on study design:

TEST SITE
- Area of exposure: 2.5 × 2.5 cm
- % coverage: no data
- Type of wrap if used: wipe of 2.5×2.5 + plastic film of the same size + rubber dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: at 24 h removal of the patch


SCORING SYSTEM: according to OECD 404 descriptions

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

0

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 72h (no 48h scoring)

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 72h ( no 48h scoring)

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Results 5

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Results 7

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Mean 24, 48, and 72 hour scores not specified

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: Mean 24, 48, and 72 hour scores not specified

Irritant / corrosive response data:

See below Table 7.3.1/1

Other effects:

No systemic effect was observed following exposure to BP Solvent IH/Isohexadecan. Behavior, general state, fur, food consumption and body weight development were normal.

Any other information on results incl. tables

Table 7.3.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
24 h	0/1/1	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 72h	0-0-0	0-0-0
Reversibility*	c	-
Average time (unit) for reversion	72h	-

* Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, BP solvent IH/Isohexadecane is not classified as skin irritant according to the criteria of annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.

Executive summary:

The skin irritating properties of the substance BP solvent IH/isohexadecane was assessed in White Vienna rabbits (3 animals of both sexes). The test substance was applied on a wipe put in contact with the shaved skin under semi-occlusive dressing for 24 hours. At the end of exposure, skin reactions were recorded both at 24 hours (patch removal) and 48 hours after the end of exposure (i.e. 72 -hour time observation) according to the Draize scale. Complete observation time was 14 days.

Moreover, the behavior, general state and food consumption were also observed. Body weight was measured every day. There was a very slight erythema (score 1) in two rabbits at patch removal (observation time = 24h). At the 72-hour observation, no erythema was observed in all 6 animals. No oedema was noted in any animal at any observation time.

No systemic effect was observed following exposure to BP Solvent IH/Isohexadecan. Behavior, general state, fur, food consumption and body weight development were normal.

Under these test conditions, the substance BP solvent IH/Isohexadecan is not classified as a skin irritant according to annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.