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EC number: 951-495-3 | CAS number: -
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Endpoint summary
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
- 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.
- Qualifier:
- equivalent or similar to guideline
- 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 or test system 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:
- 24/48/72 h
- Score:
- 3.9
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Remarks:
- Observation only at 24 and 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.96
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Remarks:
- Observation only at 24 and 72 hours
- 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.
- 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.
Reference
|
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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- 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.
- Qualifier:
- equivalent or similar to guideline
- 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:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- 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. .
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
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.
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