Registration Dossier

Administrative data

Description of key information

Skin and eye irritation studies on samples of diesel fuel were identified. The material was considered irritating to the skin but was not irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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:
1979-06-05 to 1976-06-20
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is an acceptable and a well-documented study report.
Justification for type of information:
See read-across justification provided in section 13.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24 hour occluded exposure duration
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: L.I.T. Rabbitry
- Age at study initiation: not reported
- Weight at study initiation: 2 to 3 kg
- Housing: individually housed in stainless steel cages with grated bottoms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Type of coverage:
occlusive
Preparation of test site:
other: on each animal, 2 sites were abraded and 2 sites were intact skin
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): not reported


VEHICLE
- Amount(s) applied (volume or weight with unit): not reported
- Concentration (if solution): not reported
- Lot/batch no. (if required): not reported
- Purity: not reported
Duration of treatment / exposure:
24 hours
Observation period:
Observations were recorded at 24 and 72 hours, and 7 and 14 days following test material administration.
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: four test sites located lateral to the midline of the back (2 sites on each side)
- % coverage: not reported
- Type of wrap if used: bandaged strips and elastic tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess test material was removed by wiping the skin with gauze sponges
- Time after start of exposure: 24 hours


SCORING SYSTEM: Draize method
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
3.9
Max. score:
4
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hour
Score:
2.96
Max. score:
4
Remarks on result:
other: intact skin
Irritant / corrosive response data:
At 24 hours the test sites were very irritated. Blisters formed, some open and with skin peeled back. At 72 hours, the sites remained very irritated, two rabbits had open sores. By day 7 most of the sites had formed scabs. By the 14th day, the skin was healing, but still dry and flaky with no hair growth on the test sites.

 

24 hours

72 hours

7 days

14 days

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Erythema

Oedema

Abraded

4.00

3.00

3.83

2.67

3.50

1.58

0.17

0

Intact

4.00

3.00

3.83

2.92

3.75

1.67

0.17

0

Primary dermal irritation score: 6.81

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean erythema and oedema scores for 24 and 72 hours are 3.9 and 2.96, respectively. Diesel fuel (market place sample) is classified as an irritant.
Executive summary:

In an skin irritation study, 3 male and 3 female New Zealand White rabbits were exposed to diesel fuel (market place sample). Before test material application, each animals was clipped of hair in an area from the shoulders to the hips and halfway down either side of the thorax. There were four exposure sites per animals (2 on each side of the midline). On the day of the study, the left posterior and right anterior site on each animal was abraded. Incisions penetrated the stratum corneum, but not the dermis. The remaining test sites were left in tact. 0.5 mL of test material was applied to gauze patches backed by plastic wrap. The patches were applied to the four test sites and were secured in place with bandage strips and elastic tape. After 24 hours, the wrapping and patches were removed. Excess test material was removed by wiping the skin with gauze sponges. Observations for erythema and oedema were recorded at 24 and 72 hours, and 7 and 14 days post-application. Erythema and oedema were scored using the Draize method.

At 24 hours the test sites were very irritated. Blisters formed, some open and with skin peeled back. At 72 hours, the sites remained very irritated, two rabbits had open sores. By day 7 most of the sites had formed scabs. By the 14th day, the skin was healing, but still dry and flaky with no hair growth on the test sites. The mean erythema and oedema scores for 24 and 72 hours are 3.9 and 2.96, respectively. Diesel fuel is classified as an irritant.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is an acceptable and a well-documented study report.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1979-05-28 to 1979-06-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD 405.
Justification for type of information:
See read-across justification provided in section 13.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Pel-freeze Farms, Inc.
- Age at study initiation: young adult
- Weight at study initiation: 2 to 3 kg
- Housing: housed in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: two weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported


IN-LIFE DATES: not reported
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
24, 48, and 72 hours
Number of animals or in vitro replicates:
four females and five males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the right eye of one male and two females were flushed for one minute with distilled warm water
- Time after start of exposure: 30 seconds


SCORING SYSTEM: Draize technique


TOOL USED TO ASSESS SCORE: fluorescein dye
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
80
Remarks on result:
other: unrinsed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
10
Remarks on result:
other: unrinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.11
Max. score:
20
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: unrinsed
Irritant / corrosive response data:
One rabbit, in the unrinsed group, exhibited minor conjunctival erythema at the 24 and 48 hour reading. All other animals were normal.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study and according to EU regulations, the test material is not irritating to eyes.
Executive summary:

In an eye irritation study, four females and five males were administered 0.1 mL of undiluted #2 home heating oil. The test material was applied to the everted lower lid of the right eye of each of the nine rabbits. The left eye served as the untreated control. In one male and one female, the test eye was flushed for one minute with distilled warm water 30 seconds after application. Ocular lesions were scored at 24, 48, and 72 hours after treatment. Fluorescein dye evaluation was used for the 24 hour scoring. Scoring was based on the Draize technique.

Only one rabbit, in the unrinsed group, exhibited minor conjunctival erythema at the 24 and 48 hour reading. All other animals were normal. Under the conditions of this study and according to EU regulations, the test material is not irritating to eyes.

This study received a Klimisch score of 1. It is classified as reliable without restrictions because it was conducted similar to guideline study OECD 405. .

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
well conducted study

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

The results of the skin irritation study in rabbits meet the criteria for classification as a skin irritant.

The level of reaction in the eye irritation study did not meet the criteria for classification.