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Toxicological information

Skin irritation / corrosion

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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

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

Resultsopen allclose all
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
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.

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