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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD guideline N°401, not GLP. Substance identification: commercial name without any details on the substance but MSDS 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: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD guideline N°401, not GLP. Substance identification: commercial name without any details on the substance but MSDS 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:
No preliminary study
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed at tested dose, see table 7.2.1/2.
Clinical signs:
Pilo-erection was observed at the tested dose for all exposed animals which was reversible at the third day of observation.
Body weight:
Body weight gain was recorded as normal.
Gross pathology:
No effect was observed at necropsy.
Other findings:
Terminal autopsy findings were normal

Table 7.2.1/2: Number of animals dead

Dose (g/kg)

Mortality ratio (No of death/No dosed)

Male

Female

Combined

5.0

0/5

0/5

0/10

Sex

Bodyweight (g) per day

1

8

15

Male

133

132

133

125

130

212

210

211

186

207

278

274

274

258

280

Female

121

114

112

123

126

164

174

166

170

184

198

204

204

198

216

Signs

No of rats in group of 5 showing signs

Male

Female

Pilo-erection

5

5

Interpretation of results:
other: Practically non toxic
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.

PETRAPAR 147 (P-147) was tested for acute oral toxicity in HC/CFY rats in a limit dose assay. The assay was conducted on a group of 10 rats (5 males, 5 females) with a dose of 5000 mg/kg b.w. administered by gavage, as supplied, in a single oral dose (maximum dose volume of 6.4 mL/kg b.w). 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 occurred. Pilo-erection
was observed in all animals shortly after dosing but not at 72-hour observation period. Body weight gain was not affected by treatment. At necropsy, macroscopic examination of main organs showed no abnormalities.


As the acute oral LD50 was found greater than 5000 mg/kg b.w. under the conditions of the test, PETREPAR 147
is not classified according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation 1272/2008.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral 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:
other: HC/CFY
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hacking and Churchill Limited, Huntington Cambridgeshire, England
- Age at study initiation: 4 to 6 weeks
- Weight at study initiation: 112 to 133g
- Fasting period before study: overnight prior to and approximately 4 hours after dosing
- Housing: by sex, randomly allocated to cages with wire mesh floors
- Diet (e.g. ad libitum): yes: standard laboratory rodent diet
- Water (e.g. ad libitum): yes
- Acclimation period: 8 days prior start of study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23 °C
- Humidity (%): 56%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h artificial lightening


IN-LIFE DATES: From 18th of May from 1st of June 1984

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data
Doses:
5000 mg/kg b.w.
No. of animals per sex per dose:
10 rats (5 males + 5 females)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at least twice a day; weighing: on days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic post mortem examination was performed. Abdominal and thoracic cavities were opened. Macroscopic appearence of abnormal organs when present was recorded.
Statistics:
no data

Results and discussion

Preliminary study:
No preliminary study
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed at tested dose, see table 7.2.1/2.
Clinical signs:
Pilo-erection was observed at the tested dose for all exposed animals which was reversible at the third day of observation.
Body weight:
Body weight gain was recorded as normal.
Gross pathology:
No effect was observed at necropsy.
Other findings:
Terminal autopsy findings were normal

Any other information on results incl. tables

Table 7.2.1/2: Number of animals dead

Dose (g/kg)

Mortality ratio (No of death/No dosed)

Male

Female

Combined

5.0

0/5

0/5

0/10

Sex

Bodyweight (g) per day

1

8

15

Male

133

132

133

125

130

212

210

211

186

207

278

274

274

258

280

Female

121

114

112

123

126

164

174

166

170

184

198

204

204

198

216

Signs

No of rats in group of 5 showing signs

Male

Female

Pilo-erection

5

5

Applicant's summary and conclusion

Interpretation of results:
other: Practically non toxic
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:

PETRAPAR 147 (P-147) was tested for acute oral toxicity in HC/CFY rats in a limit dose assay. The assay was conducted on a group of 10 rats (5 males, 5 females) with a dose of 5000 mg/kg b.w. administered by gavage, as supplied, in a single oral dose (maximum dose volume of 6.4 mL/kg b.w). 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 occurred. Pilo-erection
was observed in all animals shortly after dosing but not at 72-hour observation period. Body weight gain was not affected by treatment. At necropsy, macroscopic examination of main organs showed no abnormalities.


As the acute oral LD50 was found greater than 5000 mg/kg b.w. under the conditions of the test, PETREPAR 147
is not classified according to CLP Regulation 1272/2008.