Isohexadecane 2,2,4,4,6,8,8-heptamethylnonane

Acute Toxicity: oral

Administrative data

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:

The justification for read across is provided 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:

The justification for read across is provided 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:

other: Pilo-erection was observed at the tested dose for all exposed animals which was reversible at the third day of observation.

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

Test material information

Constituent 1

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

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:

other: Pilo-erection was observed at the tested dose for all exposed animals which was reversible at the third day of observation.

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 the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation 1272/2008.