Distillates (Fischer-Tropsch), 210-360 degree Celcius, hydrotreated, isoalkanes, cyclics, <0.1% aromatics

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 14th of November to 18th of November 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: OECD 404, GLP. Six rabbits were treated. Substance identification: code name with commercial substance name. Substance analytical certificate not available in the report.

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:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C14-C19, isoalkanes, cyclics, <2% aromatics

EC Number:

920-114-2

IUPAC Name:

Hydrocarbons, C14-C19, isoalkanes, cyclics, <2% aromatics

Constituent 2

Reference substance name:

Isopar V

IUPAC Name:

Isopar V

Constituent 3

Reference substance name:

MRD-94-974

IUPAC Name:

MRD-94-974

Details on test material:

- Name of test material (as cited in study report): MRD-94-974
- Substance type: petroleum product, UVCB
- Composition of test material, percentage of components: no data
- Physical state: colorless liquid
- Analytical purity: 100% Commercial product
- Expiration date of the lot/batch: 1999/10
- Storage condition of test material: stored at room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HRP Inc, Denver, PA
- Age at study initiation: 13 weeks
- Weight at study initiation: 1.99 to 2.29 kilograms
- Housing: single house
- Diet (e.g. ad libitum): feed administrated limited on a daily based. New feed each day, old feed discarded.
- Water (e.g. ad libitum): Automatic Watering System, ad libitum.
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65 to 70 degrees Fahrenheit
- Humidity (%): 40 to 60 % relative humidity
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

IN-LIFE DATES: From: 1994/11/15 To: 1994/11/18

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: electric clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

Dermal responses were evaluated 60 minutes, 24, 48 and 72 hours following patch removal.

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was waped using reverse osmosis water and paper towels.
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to the Draize method of scoring.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Topical application of Isopar V elicited a very slight erythema at the 60 Minute observation in two animals.
All animals survived to study termination were free of clinical sign and erythema at the 24, 48 and 72 hour observations

Other effects:

No data

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
60 minutes	0/1/0/1/0/0	0/0/0/0/0/0
24 h	0/0/0/0/0/0	0/0/0/0/0/0
48 h	0/0/0/0/0/0	0/0/0/0/0/0
72 h	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0.0	0.0
Reversibility*	-	-
Average time (unit) for reversion	-	-

*Reversibility: c. = completely reversible;= not completely reversible; n. = not 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, MRD-94-974 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, six young adult male New Zealand White rabbits were dermally exposed to 0.5 mL of MRD-94 -974. 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 all animals at 24, 48 and 72 hours after patch removal.

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

Based upon the directive 67/548/EEC and the CLP Regulation 1272/2008, MRD-94-974 is not considered as irritating to the rabbit skin.