Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restriction because it was conducted similar to OECD Test Guideline 401.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

other:

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Light paraffinic distillate solvent extract (CAS# 64742-05-8)

IUPAC Name:

Light paraffinic distillate solvent extract (CAS# 64742-05-8)

Details on test material:

Treated distillate aromatic extracts (TDAEs) are a further processing of distillate aromatic extracts (DAEs) in an attempt to reduce the amount of 3-7 ring PAC that is present. Since the treatment is mostly a selective reduction of PACs, the data from DAEs can serve as read across where treatment was insufficient and a significant amount of PACs still remain (≥ 3 wt% DMSO extractables as measured by IP-346). 

- Name of test material (as cited in study report): API 83-16
- Physical state: liquid, brown

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation: 7 weeks old
- Weight at study initiation: 316 to 346 g (males), 234 to249 g (females)
- Fasting period before study: overnight before dosing
- Housing: group cages
- Diet (e.g. ad libitum): Purina certified rodent chow 5002, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23
- Humidity (%): 52 to 66
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 12/03/84 To: 12/17/84

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.43 mL/kg body weight based upon average bulk density of 0.92 g/mL = 5000 mg/kg body weight

Doses:

5000 mg/kg body weight

No. of animals per sex per dose:

5 per sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed for clinical signs and mortality at hourly intervals during the first 6 hours after test material administration and twice daily thereafter for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

0/10

Clinical signs:

other: Included: hypoactivity, ataxia, red stained face, yellow-stained anal area, diarrhoea, and oily haircoat. All animals had returned to normal within 8 days of test material administration.

Gross pathology:

No visible lesions

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information LD50>5000 mg/kg bw Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study oral LD50 for male and female rats administered light paraffinic distillate solvent extract was greater than 5000 mg/kg body weight. According to EU criteria, the test material is not classified.

Executive summary:

Justification for Read Across

Treated distillate aromatic extracts (TDAEs) are a further processing of distillate aromatic extracts (DAEs) in an attempt to reduce the amount of 3-7 ring PAC that is present. Since the treatment is mostly a selective reduction of PACs, the data from DAEs can serve as read across where treatment was insufficient and a significant amount of PACs still remain (≥ 3 wt% DMSO extractables as measured by IP-346). Where treatment was sufficient to reduce the 3-7 ring PACs (<3 wt% DMSO extractables as measured by IP-346), the material is most similar to a lubricating base oil and it is this data that should be used for read across. 

In an acute oral toxicity study, groups of fasted, 7 week old Sprague-Dawley rats (5/sex) were given a single oral dose of undiluted light paraffinic distillate solvent at a dose of 5000 mg/kg body weight. Animals were observed for 14 days. Clinical signs observed included: hypoactivity, ataxia, red stained face, yellow-stained anal area, diarrhoea, and oily haircoat. All animals had returned to normal within 8 days of test material administration. The oral LD50 was determined to be greater than 5000 mg/kg body weight in males and females.

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted similar to OECD Test Guideline 401.