Hydrocarbons, C13-18

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From the 14th to the 28th of June 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

No guideline claimed but test procedure in accordance with guideline and described in sufficient details. Substance analytical certificate not available. Test substance information available from the manufacturer for code name (C14-C17 normal Paraffins)

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

Study period:

From the 14th to the 28th of June 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

No guideline claimed but test procedure in accordance with guideline and described in sufficient details. Substance analytical certificate not available. Test substance information available from the manufacturer for code name (C14-C17 normal Paraffins)

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Guideline principles

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Taconic Farms, Germantown, New York
- Age at study initiation: 10-11 weeks of age
- Weight at study initiation: 189 to 317 grams
- Fasting period before study: overnight
- Housing: suspended stainless steel
- Diet (e.g. ad libitum): Purina rodent chow ad libitum
- Water (e.g. ad libitum): yes
- Acclimation period: 21 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24
- Humidity (%): 40 to 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 14 June 1983 To: 28 June 1983

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No additional data

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 rats/sex/dose (see Table 7.2.1/1)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2, 4, 6 hours after dosing and once per day thereafter, body weights: prior to dosing and at day 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Statistics:

no data

Preliminary study:

no additional data

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality was observed during the study

Clinical signs:

other: There were few clinical in-life observations during the test period. A/G staining was observed in 5 males and 4 females animals at the 4 hour observation and in 5 males and 5 females at the 6 hours observation. Unthrifty coat was observed in 2 males and

Gross pathology:

The only gross post mortem observation noted at necropsy was lung discoloration in 7 of the 10 test animals.

Other findings:

No additional data

No additional data

Interpretation of results:

other: Practically non toxic

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, MRD-83-207 is not classified according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation 1272/2008.

Executive summary:

MRD-83-207 was tested for acute oral toxicity in Sprague-Dawley rats in a limit dose assay.
The test substance, a liquid, was administered as supplied. Animals were fasted overnight prior to treatment. 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 (via a syringe) in a single oral dose.

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 during the study. Body weight gain was not affected by treatment. A/G staining was noted in all animals within the 6-hour observation period. In-life observations also included alopecia and unkempt coat. At necropsy, macroscopic examination of main organs showed lung discoloration in seven animals.

As the acute oral LD50 was found to be greater than 5000 mg/kg b.w. under the conditions of the test, MRD-83-207 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:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Guideline principles

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Paraffin (petroleum), normal, C5-C20

IUPAC Name:

Paraffin (petroleum), normal, C5-C20

Constituent 2

Reference substance name:

MRD-83-207

IUPAC Name:

MRD-83-207

Details on test material:

- Name of test material (as cited in study report): MRD-83-207
- Substance type: Petroleum product, UVCB
- Physical state: clear liquid (density = 0.76 g/mL at room temperature)
- Analytical purity: 100% Commercial product (100% purity assumed for dosing)
- Composition of test material, percentage of components: C14-C17 normal Paraffins

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Taconic Farms, Germantown, New York
- Age at study initiation: 10-11 weeks of age
- Weight at study initiation: 189 to 317 grams
- Fasting period before study: overnight
- Housing: suspended stainless steel
- Diet (e.g. ad libitum): Purina rodent chow ad libitum
- Water (e.g. ad libitum): yes
- Acclimation period: 21 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24
- Humidity (%): 40 to 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 14 June 1983 To: 28 June 1983

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No additional data

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 rats/sex/dose (see Table 7.2.1/1)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2, 4, 6 hours after dosing and once per day thereafter, body weights: prior to dosing and at day 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Statistics:

no data

Results and discussion

Preliminary study:

no additional data

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality was observed during the study

Clinical signs:

other: There were few clinical in-life observations during the test period. A/G staining was observed in 5 males and 4 females animals at the 4 hour observation and in 5 males and 5 females at the 6 hours observation. Unthrifty coat was observed in 2 males and

Gross pathology:

The only gross post mortem observation noted at necropsy was lung discoloration in 7 of the 10 test animals.

Other findings:

No additional data

Any other information on results incl. tables

No additional data

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, MRD-83-207 is not classified according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation 1272/2008.

Executive summary:

MRD-83-207 was tested for acute oral toxicity in Sprague-Dawley rats in a limit dose assay.
The test substance, a liquid, was administered as supplied. Animals were fasted overnight prior to treatment. 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 (via a syringe) in a single oral dose.

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 during the study. Body weight gain was not affected by treatment. A/G staining was noted in all animals within the 6-hour observation period. In-life observations also included alopecia and unkempt coat. At necropsy, macroscopic examination of main organs showed lung discoloration in seven animals.

As the acute oral LD50 was found to be greater than 5000 mg/kg b.w. under the conditions of the test, MRD-83-207 is not classified according to the criteria of Annex VI to Directive 67/548/EEC and CLP Regulation 1272/2008.