Renewable hydrocarbons, C17-C18, branched alkanes

Skin irritation / corrosion

Administrative data

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:

from 1996/04/11 to 1996/06/13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted according to OECD guideline N°404 in compliance with GLP. No test substance rinsed off after 4-hour exposure as no residual test substance noted at dressing removal Substance analytical certificate available Substance identification: information available from supplier for commercial name (Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

No test substance rinsed off after 4-hour exposure

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

Guideline study

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics

EC Number:

927-632-8

IUPAC Name:

Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics

Constituent 2

Reference substance name:

EDC 95-08

IUPAC Name:

EDC 95-08

Details on test material:

- Name of test material (as cited in study report): EDC 95-08
- Substance type: petroleum product, UVCB
- Composition of test material, percentage of components: Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics
- Substance state: colourless liquid
- Analytical purity: 100% Commercial product
- Storage condition of test material: at room temperature
- Lot/batch No.: 8865

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2.5 ± 0.1 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12 cycles/hour of filtered.
- 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:

yes, concurrent no treatment

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 after exposure (after the removal of the patch)

Number of animals:

1 animal in the first assay (to assess the irritancy of the substance) and then two remaining animals.

Details on study design:

TEST SITE
- Area of exposure: over a 2.5 cm² (approximately 6 cm²)
- % coverage: no data
- Type of wrap if used: a restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No test substance rinsed off after 4-hour exposure. No residual test substance noted at removal of the dressing
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.2

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

See Table I
- In one animal, no skin reactions were observed
- Very slight erythema was noted in the two other rabbits, at the one-hour and 24 hours readings
Mean scores over 24, 48 and 72 hours for individual animals were 0.0, 0.3 and 0.3 for erythema and 0.0 for oedema.

Other effects:

None

Any other information on results incl. tables

Table I: 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
48 h	0/0/0	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	0.0-0.3-0.3	0-0-0
Reversibility*	c	-
Average time (unit) for reversion	Within 48 h	-

* Reversibility: c. = completely reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, EDC 95-08 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 guideline N°404 in compliance with GLP, three young adult New Zealand White rabbits were dermally exposed to 0.5 mL of EDC 95-08. Test sites were covered with a semi-occlusive dressing for 4 hours. The skin reactions were assessed at 1, 24, 48 and 72 hours after removal of the dressing. The mean score was calculated across 3 scoring times for individual animals: 24, 48 and 72 hours after patch removal, for each animal separately.

The mean individual scores over 24, 48 and 72 hours were 0.0, 0.3 and 0.3 for erythema and 0.0 for oedema.

Based upon the directive 67/548/EEC and the CLP Regulation 1272/2008, EDC 95-08 is not considered as irritating to the rabbit skin.