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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 10th and 14th of May, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD guideline N°402 but not in compliance with GLP. Details on the substance provided by the manufacturer.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Between 10th and 14th of May, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD guideline N°402 but not in compliance with GLP. Details on the substance provided by the manufacturer.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Preliminary study:
Not applicable
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was observed
Clinical signs:
No treatment related clinical signs were observed
Body weight:
No treatment related change has been observed. See Table 7.2.3/2 for details.
Gross pathology:
Two small areas of necrosis were observed at the treatment site on two male rats on Day 2. Recovery from this was complete on Day 6 and 9 respectively.
Other findings:
- Other observations:
Cutaneous reactions: Slight to well-defined erythema and slight oedema were observed at the treatment sites of all animals. Recovery was generally complete by Day 6 with the exception of one male rat which showed slight oedema until Day 9.
On Day 6 all the rats developed small, slightly raised erythematous areas at the dose site. Signs of recovery from this were indicated on Day 9 when small focal scab formations were observed. These persisted until Day 15 in all rats except two females which had completely recovered by Day 14.
See Table 7.2.3/3 for details.

No sign of systemic toxicity.
Terminal autopsy findings were normal.

Table 7.2.3/2: Individual bodyweights of rats dosed dermally with P-147:

Sex

Bodyweight (g) at Day

1

8

15

Females

250

308

378

248

291

354

250

300

375

250

297

364

250

312

383

Males

216

239

269

222

234

266

214

227

253

215

232

259

212

231

253

Table 7.2.3/3: Irritant/corrosive response data for each animal at each observation time

Score at time point

Erythema

Oedema

Max. score: 4

Max. score: 4

M

F

M

F

Day 2

2/2/1/2/2

1/2/1/1/1

0/0/0/0/0

0/0/0/0/0

Day 3/4/5

2/2/2/2/2

2/2/2/2/2

1/1/1/1/1

1/1/1/1/1

Day 6/7/8

0/0/0/0/0

0/0/0/0/0

1/0/0/0/0

0/0/0/0/0

Day 9 -14

0/0/0/0/0

0/0/0/0/0

0/0/0/0/0

0/0/0/0/0

Interpretation of results:
other: Practically nontoxic
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, Petrepar-147 is not classified according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation 1272/2008.
Executive summary:

This data is being read across from the source study that tested Hydrocarbons, C14-C17, n-alkanes, <2% aromatics based on analogue read across.

Petrepar P-147 was tested for acute dermal toxicity in HC/CFY (remote Sprague-Dawley) rats in a limit dose assay according to OECD guideline N°402. The test substance, a liquid, was administered undiluted as supplied. A 10% total body surface of hair was removed from the dorso-lumbar region with clippers in every animal. The assay was conducted on a group of 10 rats (5 males, 5 females) with a dose of 2000 mg/kg b.w. administered by spreading in a single dermal dose (maximum dose volume of 2.6 mL/kg b.w). After test substance application an occlusive patch was held in place for 24 hours. Skin was washed with water at the end of the 24-hour exposure period.
Examinations for mortality, clinical signs and body weight gain were performed during the 14-day observation period. All surviving animals were necropsied at the end of the observation period.
No deaths and clinical signs occurred during the observation period.

Body weight gain was not affected by treatment. At necropsy, macroscopic examination of main organs showed no abnormalities.

Slight to well-defined and slight oedema was observed at the site of treatment in all animals. Reversibility was generally observed by day 6 with the exception of one animal showing slight oedema until Day 9. All rats developed small, slightly raised erythematous areas at the dose site on the day 6. Then, small focal scab formations persisted from day 9 to day 15 in all rats except two females which had recovered by day 14. Two small areas of necrosis were observed at the treatment site on two males on day 2 but not on day 6 and day 9, respectively.


As the acute dermal LD50 was greater than 2000 mg/kg b.w. under the test conditions, Petrepar P-147 is not classified according to the criteria of Annex VI to Directive 67/548/EEC and CLP Regulation 1272/2008.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
Guideline study
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrocarbons, C14-C17, n-alkanes, <2% aromatics
EC Number:
917-828-1
Molecular formula:
none available - not a single isomer - see remarks
IUPAC Name:
Hydrocarbons, C14-C17, n-alkanes, <2% aromatics
Constituent 2
Reference substance name:
Petrepar 147 (P-147)
IUPAC Name:
Petrepar 147 (P-147)
Details on test material:
- Name of test material (as cited in study report): Petrepar 147 (P-147)
- Substance type: petroleum product, UVCB
- Physical state: colourless liquid
- Analytical purity: 100 % commercial product
- Composition of test material, percentage of components: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS: HC/CFY (Remote Sprague-Dawley)
- Source: Hacking and Churchill Limited, Huntington, Cambridgeshire, England
- Age at study initiation: approximately 6 to 8 weeks of age
- Weight at study initiation: 212 to 215 g
- Housing: individually in metal cages with wire mesh floors
- Diet: Standard laboratory rodent diet (Laboratory Diet No. 1, Spratt's Rodent Breeding Diet), ad libitum
- Water: ad libitum. Examination at source are conducted quarterly.
- Acclimation period: minimum 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): mean: 55%
- Air changes: approximately 15 per hour
- Photoperiod: artificial light, 12 hrs light, 12 hrs dark.


Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10% of the total body surface.
Hair was removed one day prior to treatment, no shaving or chemical depilation was used.
- Type of wrap if used: gauze held with an impermeable dressing encircled firmly around the trunk


REMOVAL OF TEST SUBSTANCE
- Washing: in warm (30-40°C) water. Dry with absorbent paper
- Time after start of exposure: at the end of the 24-hour exposure


TEST MATERIAL
- Concentration (if solution): not exceeding 2.6 mL/kg
- Constant volume or concentration used: yes/no
Duration of exposure:
24 hours
Doses:
2000 mg/kg b.w. applied by spreading
No. of animals per sex per dose:
5 animals / sex / dose (see Table 7.2.3/1)
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: soon after dosing, then at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed at least twice.
- Observation of treated areas: daily for signs or dermal irritation
- Necropsy of survivors performed: yes, after cervical dislocation animals were subjected to a macroscopic examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of abnormal organs, if present, was recorded.
- Other examinations performed:
clinical signs: recorded at each observation
body weight: on Day 1, 8 and 15
Statistics:
No data

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality was observed
Clinical signs:
No treatment related clinical signs were observed
Body weight:
No treatment related change has been observed. See Table 7.2.3/2 for details.
Gross pathology:
Two small areas of necrosis were observed at the treatment site on two male rats on Day 2. Recovery from this was complete on Day 6 and 9 respectively.
Other findings:
- Other observations:
Cutaneous reactions: Slight to well-defined erythema and slight oedema were observed at the treatment sites of all animals. Recovery was generally complete by Day 6 with the exception of one male rat which showed slight oedema until Day 9.
On Day 6 all the rats developed small, slightly raised erythematous areas at the dose site. Signs of recovery from this were indicated on Day 9 when small focal scab formations were observed. These persisted until Day 15 in all rats except two females which had completely recovered by Day 14.
See Table 7.2.3/3 for details.

No sign of systemic toxicity.
Terminal autopsy findings were normal.

Any other information on results incl. tables

Table 7.2.3/2: Individual bodyweights of rats dosed dermally with P-147:

Sex

Bodyweight (g) at Day

1

8

15

Females

250

308

378

248

291

354

250

300

375

250

297

364

250

312

383

Males

216

239

269

222

234

266

214

227

253

215

232

259

212

231

253

Table 7.2.3/3: Irritant/corrosive response data for each animal at each observation time

Score at time point

Erythema

Oedema

Max. score: 4

Max. score: 4

M

F

M

F

Day 2

2/2/1/2/2

1/2/1/1/1

0/0/0/0/0

0/0/0/0/0

Day 3/4/5

2/2/2/2/2

2/2/2/2/2

1/1/1/1/1

1/1/1/1/1

Day 6/7/8

0/0/0/0/0

0/0/0/0/0

1/0/0/0/0

0/0/0/0/0

Day 9 -14

0/0/0/0/0

0/0/0/0/0

0/0/0/0/0

0/0/0/0/0

Applicant's summary and conclusion

Interpretation of results:
other: Practically nontoxic
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, Petrepar-147 is not classified according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation 1272/2008.
Executive summary:

Petrepar P-147 was tested for acute dermal toxicity in HC/CFY (remote Sprague-Dawley) rats in a limit dose assay according to OECD guideline N°402. The test substance, a liquid, was administered undiluted as supplied. A 10% total body surface of hair was removed from the dorso-lumbar region with clippers in every animal. The assay was conducted on a group of 10 rats (5 males, 5 females) with a dose of 2000 mg/kg b.w. administered by spreading in a single dermal dose (maximum dose volume of 2.6 mL/kg b.w). After test substance application an occlusive patch was held in place for 24 hours. Skin was washed with water at the end of the 24-hour exposure period.
Examinations for mortality, clinical signs and body weight gain were performed during the 14-day observation period. All surviving animals were necropsied at the end of the observation period. No deaths and clinical signs occurred during the observation period.

Body weight gain was not affected by treatment. At necropsy, macroscopic examination of main organs showed no abnormalities.

Slight to well-defined and slight oedema was observed at the site of treatment in all animals. Reversibility was generally observed by day 6 with the exception of one animal showing slight oedema until Day 9. All rats developed small, slightly raised erythematous areas at the dose site on the day 6. Then, small focal scab formations persisted from day 9 to day 15 in all rats except two females which had recovered by day 14. Two small areas of necrosis were observed at the treatment site on two males on day 2 but not on day 6 and day 9, respectively.


As the acute dermal LD50 was greater than 2000 mg/kg b.w. under the test conditions, Petrepar P-147 is not classified according to the criteria of Annex VI to Directive 67/548/EEC and CLP Regulation 1272/2008.