Registration Dossier

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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
other:
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
RAEs are not expected to be more hazardous than DAE; therefore, read across to DAEs represents a conservative approach.

- Name of test material (as cited in study report): API 83-16
- Physical state: liquid, brown
- Light paraffinic distillate solvent extract
Specific details on test material used for the study:
- Name of test material (as cited in study report): API 83-16
- Physical state: Liquid, brown
- Viscosity, SSU: 67.2 at 100°F
- API Gravity: 16.7
- Flash Point: (°F) 335
- Pour Point (°F): 20
- Aniline Point (°F): 95.5
- Sulfur, Wt %: 2.64

- Composition of test material ASTM D-2007, Wt. %:
Saturates: 29.2
Aromatics 68.6

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
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.
Body weight:
Initial: 314g (male), 231g (female)
Day 7: 343g (male), 246g (female)
Terminal: 386g (male), 267g (female)
Gross pathology:
No visible lesions

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information 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

For purposes of classification and labelling and registration under REACH, aromatic extracts are sub-divided into the categories of distillate aromatic extracts (DAE), treated distillate aromatic extracts (TDAE), and residual aromatic extracts (RAE). Some of the classifications are based on 3-7 ring PAC content, which is not substantively affected by whether the aromatic extract is derived from paraffinic or naphthenic or “light” or “heavy” crude. Therefore, DAEs and RAEs are not subclassified based on crude oil source or viscosity. For most health endpoints, data from any one of the DAEs can be “read-across” to the remaining DAEs and whole RAE category. 

 

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.