Petrolatum (petroleum), oxidized, Bu ester

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:

26 November 2001 to 30 November 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, conducted to a valid guideline and was performed under GLP conditions. Since the study was conducted with the read across substance, hydrocarbon waxes (petroleum), oxidised, it has been assigned a reliability score of 2. Read across from this substance is justified on the basis of its similar physical and chemical properties to those of the registered substance. Furthermore, it has a very similar chemical structure; the registered substance is an esterified form of the read across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbon waxes (petroleum), oxidized

EC Number:

265-205-1

EC Name:

Hydrocarbon waxes (petroleum), oxidized

Cas Number:

64743-00-6

Molecular formula:

Not applicable to a UVCB substance

IUPAC Name:

Hydrocarbon waxes (petroleum), oxidized

Test material form:

other: greasy solid

Details on test material:

- Physical appearance: Light brown semi-solid
- Storage: Room temperature and humidity
- Acid number: 24-40

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, PA, USA
- Date received: 31 October 2001
- Age at study initiation: approximately 12 weeks
- Weight at study initiation: 2.5 - 2.8 kg
- Housing: Individually in suspended wire cages
- Diet: Fresh Purina Rabbit Chow, Diet # 5321, supplied by Purina Mills, Inc. (provided daily)
- Water: ad libitum
- Quarantine period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled
- Photoperiod (hrs dark / hrs light): 12 hrs light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/rabbit.

Duration of treatment / exposure:

4 hours

Observation period:

Up to 72 hours

Number of animals:

Three in total, two females and one male

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: The torso was wrapped with plastic

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with distilled water
- Time after start of exposure: Immediately after patch removal

OBSERVATIONS
- Time points: 60 minutes, 24, 48 and 72 hours
- Dermal reaction, ulceration, necrosis or any evidence of tissues destruction were recorded at each time point
- General health was recorded at each time point
- Body weights were recorded before exposure and at termination

SCORING SYSTEM: Erythema and edema were scored according to the Draize scale (1977), which can be seen in table 1

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Other effects:

- No abnormal physical signs were noted during the observation period.
- One animal lost body weight, all other weight changes were normal.

Any other information on results incl. tables

Table 2. Results of Observed Dermal Reactions

Observation	Animal and Sex	Time after patch removal				Average Score of 24, 48 and 72 hrs.
		60 (mins)	24 (hrs)	48 (hrs)	72 (hrs)
Erythema Score	Female No. 1	2	1	0	0	0.33
	Female No. 2	1	1	0	0
	Male No. 3	1	1	0	0
Edema Score	Female No. 1	0	0	0	0	0.11
	Female No. 2	0	0	0	0
	Male No. 3	1	1	0	0

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The study report concludes that the test material is a dermal irritant. However, under the conditions of the study, the test material did not elicit any reaction in any of the animals during the course of the study that meant the test material required classification as a skin irritant according to Regulation (EC) 1272/2008. Therefore the results have been interpreted as "not classified" according to EU criteria.

Executive summary:

In a GLP compliant dermal irritation study performed according to the standardised guideline EPA OPPTS 870.2500, three rabbits were exposed to the test material for a period of 4 hours. The average dermal reaction, taken from observations at 24, 48 and 72, were scored according to the Draize (1977) scale, and recorded. The mean score for erythema was 0.33 while the mean score for edema was 0.11; all observed signs of irritation completely reversed within 48 hours. Under the conditions of the study, the test material did not elicit any reaction in any of the animals during the course of the study that meant the test material required classification as a skin irritant according to Regulation (EC) 1272/2008. Therefore the results have been interpreted as "not classified" according to EU criteria.