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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:
1984-05-10 to 1984-05-24
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because although it was conducted similar to OECD guideline 404 and was GLP compliant, the exposure was 24 hours. The current recommended exposure duration is 4 hours.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Skin was not evaluated 24 hours after patch removal because skin was occluded for 24 hours, not the recommended 4 hours.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
64741-44-2
Cas Number:
64741-44-2
IUPAC Name:
64741-44-2
Constituent 2
Reference substance name:
Straight run middle distillate
IUPAC Name:
Straight run middle distillate
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Straight run middle distillate (API 83-11)
- Name of test material (as cited in study report): API 83-11
- Molecular formula (if other than submission substance): Straight run middle distillate
- Clear, light yellow liquid
- CAS number: 64741-44-2
- Gravity API: 36.2
- Sulfur wt %:0.30
- Nitrogen ppm: 80
- Boiling range (ASTM D-86 equiv) 10%: 488 °F
- Initial Boiling Point 366 °F
- End Boiling Point 735 °F
- Viscosity at 40°C cSt: 4.16
- Aniline Point °F: 171
- Composition % by MS:
olefins 2.0
aromatics 21.0
saturates 77.0

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazelton Dutchland., Inc., Denver, Pennsylvania
- Age at study initiation: Approximately 16 weeks
- Weight at study initiation: 2.3 kilograms to 2.6 kilograms
- Housing: Individually in screen bottom cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 25
- Humidity (%): 58% to 65%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

IN-LIFE DATES: From: 1984-05-10 To: 1984-05-24

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and shaved/abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 millilitres



Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
Six
Details on study design:
TEST SITE
- Area of exposure: Back and flanks
- % coverage: Not reported
- Type of wrap if used: Gauze overwrapped with Saran Wrap and Elastoplast tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wet disposable paper towels were used to wipe the test compound away from the area as much as possible, post exposure, without causing irritation.
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
2.2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: intact skin
Irritant / corrosive response data:
Individual Dermal Irritation Scores
Erythmea Oedema
Intact Abraded Intact Abraded
24 hours 2, 1, 2, 2, 3, 2 2, 1, 2, 2, 3, 1 2, 1, 2, 2, 3, 2 2, 1, 2, 2, 3, 1
72 hours 2, 1, 2, 2, 2, 1 2, 1, 2, 1, 2, 1 1, 1, 1, 1, 1, 1 1, 1, 1, 0, 1, 0
96 hours 2, 1, 1, 1, 2, 1 1, 1, 1, 1, 1, 1 1, 1, 0, 0, 1, 0 1, 1, 0, 0, 1, 0
7 days 0, 1, 0, 1, 1, 1 0, 1, 0, 0, 1, 0 0, 0, 0, 0, 1, 0 1, 1, 0, 0, 1, 0
14 days 0, 0, 0, 0, 0, 0 0, 0, 0, 0, 0, 0 0, 0, 0, 0, 0, 0 0, 0, 0, 0, 0, 0

Other effects:
No other effects were noted.

Any other information on results incl. tables

Slight to moderate erythema and oedema were present at 24 hours (negligible difference in response between intact and abraded sites) and gradually resolved over 96 hours with barely perceptible reactions remaining at 7 days. Mean primary dermal irritation scores (that is, the sum of the irritation score for each site divided by the number of animals at each observation period) are presented below:

Time

Erythema

Oedema

24 hours

2.0-1.8

2.2-2.0

72 hours

1.7-1.5

1.0-0.7

96 hours

1.3-1.0

0.5

7 days

0.7-0.3

0.2-0.5

14 days

0-0

0-0

 

The primary dermal irritation index (representing the sum of 24 and 72 hour primary dermal irritation scores for intact and abraded skin, 8 values, divided by 4) was 3.2. Based on the severity of skin reactions present up to 72 hr, straight run middle distillate is condered moderately irritating to rabbit skin following 24 -hour occluded contact.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Exposure period was 24 hours not the recommended 4 hours Criteria used for interpretation of results: EU
Conclusions:
Based on the severity of skin reactions present up to 72 hr, straight run middle distillate is not irritating to rabbit skin following 24 hour occluded contact according to the study author.
Executive summary:

A straight run middle distillate was tested for primary dermal irritancy in New Zealand White rabbits. The sample (0.5 mL) was applied to intact and abraded clipped skin on the back and flank of 6 rabbits, under occlusion for 24 hours. Dermal irritation was scored according to the method of Draize at 24, 72 and 96 hours, and 7 and 14 days after application of the test material. Slight to moderate erythema and oedema were present at 24 hours (negligible difference in response between intact and abraded sites) and gradually resolved over 96 hours with barely perceptible reactions remaining at 7 days. Mean primary dermal irritation scores (that is, the sum of the irritation score for each site divided by the number of animals at each observation period).

The primary dermal irritation index (representing the sum of 24 and 72 hour primary dermal irritation scores for intact and abraded skin (8 values) divided by 4) was 3.2. For intact skin, the mean erythema and oedema scores over 24 to 72 hours were 1.80 and 1.58, respectively. Although the test material is not classified under EU criteria because the exposure duration is 24 hours and not the recommended 4 hours, it appears to be not irritating based on the mean erythema and oedema scores. Additionally, since the exposure period was 24 hours, mean erythema and oedema scores are considered conservative.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because although it was conducted similar to OECD guideline 404 and was GLP compliant, the exposure was 24 hours. The current recommended exposure duration is 4 hours.

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