Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
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 is similar to OECD Test Guideline 402.

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 402 (Acute Dermal 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, CAS No. 64742-05-8
- 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:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver, Pennsylvania

- Weight at study initiation: 2455 to 3134 grams
- Housing: maintained individually in screen-bottom cages
- Diet (e.g. ad libitum): Purina certified rabbit chow 5322, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24
- Humidity (%): 56 to 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back, 2 male and 2 female rabbits in each dosage had their skin abraded
- % coverage: 10% of total body area
- Type of wrap if used: wrapped with an eight-ply gauze bandage and overwrapped with saran wrap and elastoplast tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped clean with wet disposable paper towels
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 to 3000 mg/kg body weight

Duration of exposure:
24 hours
Doses:
2000 mg/kg body weight, 3000 mg/kg body weight
No. of animals per sex per dose:
4
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 hourly for the first 6 hours and then daily for dermal irritation and twice daily for clinical signs of mortality for a period of 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Mortality:
No mortality was observed in any of the 3000 mg/kg body weight dosage levels, one female with intact skin
Clinical signs:
At the 2000mg/kg bw dosage level: diarrhoea, dyspnoea, hypoactivity, prostration, emaciation, soft stool
At the 3000mg/kg bw dosage level: no signs of systemic toxicity (or mortality)
Dermal irritation was observed and ranged from slight to severe for erythema and oedema
Body weight:
Average Body Weights (g) male-
2000mg/kg bw (intact): Initial (2955), Day 7 (2854), Terminal (3142)
2000mg/kg bw (abraded): Initial (2907), Day 7 (2843), Terminal (3106)
3000mg/kg bw (intact): Initial (2619), Day 7 (2448), Terminal (2656)
3000mg/kg bw (abraded): Initial (2772), Day 7 (2674), Terminal (2957)
Average Body Weights (g) female-
2000mg/kg bw (intact): Initial (2821), Day 7 (2592), Terminal (2900)
2000mg/kg bw (abraded): Initial (2955), Day 7 (2596), Terminal (3007)
3000mg/kg bw (intact): Initial (2663), Day 7 (2485), Terminal (2373)
3000mg/kg bw (abraded): Initial (2680), Day 7 (2666), Terminal (2939)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information LD50 > 3000 mg/kg body weight Criteria used for interpretation of results: EU
Conclusions:
The estimated dermal LD50 is greater than 3000 mg/kg body weight in males and females.
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 dermal toxicity study, groups of New Zealand White rabbits (8/sex) were dermally exposed to undiluted light paraffinic distillate solvent extract for 24 hours to 10% of total body area at doses of 2000 and 3000 mg/kg bw. Animals then were observed for 14 days.

At the 2000 mg/kg bw dosage level: diarrhoea, dyspnoea, hypoactivity, prostration, emaciation, soft stool. At the 3000mg/kg bw dosage level: no signs of systemic toxicity (or mortality). Dermal irritation was observed and ranged from slight to severe for erythema and oedema. The dermal LD50 was determined to be greater than 3000 mg/kg body weight in both males and females. According to EU criteria, the test material is not classified.

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because it is similar to OECD Test Guideline 402.