Reaction products of petrolatum (petroleum), oxidized, esterified with methanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 December 2000 to 15 December 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

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, Me esters, calcium salts

EC Number:

271-638-7

EC Name:

Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts

Cas Number:

68603-11-2

Molecular formula:

not available

IUPAC Name:

Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts

Test material form:

other: semi-solid

Details on test material:

- Physical state: brown semi-solid
- Storage condition of test material: room temperature and humidity

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
- Weight at study initiation: 2.2 - 2.6 kg
- Housing: individually in suspended wire cages. Bedding was placed underneath the cages and changed at least three times per week.
- Diet: Fresh Purina Rabbit Chow (Diet #5321) was provided daily
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Animals were kept in a temperature-controlled room with a 12 hour light/dark cycle.

IN-LIFE DATES: From 29 November 2000 to 15 December 2000

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

72 hours following patch removal

Number of animals:

3 (2 males, 1 female)

Details on study design:

TEST SITE
- Area of exposure: on the day prior to exposure, an area of approximately 10 x 15 cm on the dorsal trunk of each animals was clipped free of hair. 0.5 mL test material was applied to the test site.
- Type of wrap if used: the test material was covered with a 2.5 x 2.5 cm, 4 ply, gauze patch which was secured with non-irritating tape. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the exposure period the wrappings were removed. Residual test material was removed from the test sites by gentle washing with distilled water prior to scoring for dermal reaction.
- Time after start of exposure: 4 hours

SCORING SYSTEM:
The Draize scale, presented as Table 1 in the field "Any other information on material and methods incl. tables" was used to assess the degree of erythema and oedema at the application sites approximately 1 hour and 1, 2 and 3 days after the removal of the dressings. Any other clinical signs were also noted. Bodyweights were measured and recorded immediately before dose administration and at the 72 hour examination.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.56

Max. score:

2

Reversibility:

fully reversible within: 3 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 2 days

Irritant / corrosive response data:

Erythema was barely perceptible at 60 minutes following patch removal, barely perceptible to well defined at 24 hours, absent to barely perceptible at 48 hours, and absent at 72 hours. Oedema was absent to barely perceptible at 60 minutes and 24 hours following patch removal, and absent at 48 and 72 hours.

Other effects:

There were no abnormal physical signs noted during the observation period. The dose site on one animal was stained yellow throughout the 72 hour observation period.
All bodyweight changes were normal.

Any other information on results incl. tables

Table 2: Results

Sex	M	M	F
Pre-test bodyweight (kg)	2.5	2.6	2.2
Terminal bodyweight (kg)	2.8	2.8	2.2
Time after patch removal (h)	Erythema
1	1a	1a	1a
24	1	1	2a
48	0	0	1a
72	0	0	0a
	Edema
1	1	1	0
24	1	0	1
48	0	0	0
72	0	0	0
	Systemic observations
1	A	A	A
24	A	A	A
48	A	A	A
72	A	A	A

A = Normal

a = dose site stained yellow

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, 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 in accordance with EU criteria. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.

Executive summary:

The skin irritation potential of the test material was determined in accordance with the standardised guideline EPA OPPTS 870.2500.

Three New Zealand White rabbits received a single four hour semi-occluded application of 0.5 mL of the test material and were assessed for the following 3 days for any signs of skin irritation. Erythema was barely perceptible at 60 minutes following patch removal, barely perceptible to well defined at 24 hours, absent to barely perceptible at 48 hours and absent at 72 hours. Oedema was absent to barely perceptible at 60 minutes and 24 hours following patch removal, and absent at 48 and 72 hours. There were no abnormal physical signs noted during the observation period and all bodyweight changes were normal.

Under the conditions of the test, 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 in accordance with EU criteria.