Alkanes, C14-17-branched and linear

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 1984/05/23 and 1984/06/01

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to OECD guideline N°404 but not in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Guideline study

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C14-C17, n-alkanes, <2% aromatics

EC Number:

917-828-1

Cas Number:

185857-35-6

Molecular formula:

none available - not a single isomer - see remarks

IUPAC Name:

Hydrocarbons, C14-C17, n-alkanes, <2% aromatics

Constituent 2

Reference substance name:

Petrepar 147 (P-147)

IUPAC Name:

Petrepar 147 (P-147)

Details on test material:

- Name of test material (as cited in study report): Petrepar 147 (P-147)
- Substance type: petroleum product, UVCB
- Physical state: colourless liquid
- Analytical purity: 100 % commercial product
- Composition of test material, percentage of components: no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking and Churchill Ltd. Huntingdon; Cambridgeshire
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 2.1-2.3kg
- Housing: individually
- Diet (e.g. ad libitum): SDS, standard rabbit diet
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30-70 %
- Air changes (per hr): 19 times/hour
- Photoperiod (hrs dark / hrs light): 12 h/ 12h


IN-LIFE DATES: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: Electric clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

Skin reaction assessed at 1, 24, 48 and 72 hours, and 5, 10 days after exposure (after the removal of the patch)

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm square gauze pads
- % coverage: no data
- Type of wrap if used: Each treatment site was occluded with "Elastoplast" elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treatment site was washed using distilled water to remove any residual test substance
- Time after start of exposure: just after 4 hours exposure


SCORING SYSTEM: in accordance with the OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 0.67 - <= 2

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 0 - <= 1.33

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

See Table I, the test substance is slightly irritating:
- Very slight reactions were seen in two animals during the 4 days observation period. The skin of both animals was normal on day 4
- Very slight erythema was seen in the third animal following removal of the bandage. By day 2, well defined erythema with slight oedema had developed and persisted to day 8. The skin was normal on day 10.

Other effects:

None

Any other information on results incl. tables

Table 5.2.1/1: 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	1/1/2	0/0/0
48 h	1/1/2	0/1/2
72 h	0/0/2	0/1/2
Average 24h, 48h, 72h	0.67-0.67 -2	0-0.67 -1.33
Reversibility*	c	c
Average time (unit) for reversion	within day 10	within day 10

C: completely 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, Petrepar-147 is not classified as skin irritant according to the criteria of Annex VI of the Directive 67/548/EEC and the CLP Regulation 1272/2008.

Executive summary:

In a primary dermal irritation study conducted according to OECD 404 without compliance in GLP, three rabbits were exposed to 0.5 mL of Petrepar-147. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals then were observed for 10 days. The skin reactions were assessed at 1, 24, 48 and 72 hours, as well as 5 and 10 days after removal of the dressing. The mean score was calculated across 3 scoring times; 24, 48 and 72 hours after patch removal, for each animal separately.

The mean individual scores were 0.67, 0.67, 2.0 for erythema and 0.00, 0.67, 1.33 for edema. Skin reactions were totally reversible at day 10. Petrepar-147 is slightly irritating.

Based upon the directive 67/548/EEC and the CLP Regulation 1272/2008, Petrepar-147 is not considered as irritating to the rabbit skin.