Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 Oct. – 05 Nov. 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid: viscous
Details on test material:
- Manufacturers identification: Novares TL 10, Novares L 100, Novares L 800, Novares C 10 (different types/technical products of the substance)
- Substance type: organic
- Test material is 'Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised', EC list number 701-299-7 (assigned by ECHA after request for change of EC number/EC name). Originally, the substance Hydrocarbons, C9-unsaturated, polymerised, CAS No. 71302- 83-5, was submitted for registration. Subsequent to substance validation, the identity of the substance was changed by ECHA (EC number 615-276-2 and new name 'Distillates (petroleum), steam-cracked, C8-12 fraction", mainly C8 - C10 unsaturated aromatic and alkylaromatic hydrocarbons, predominantly styrene- and indene-derivatives, obtained by Lewis acid-initiated alkylation and polymerisation').
- for additional information see respective study records
Specific details on test material used for the study:
- Name of test material (as cited in study report): Novares TL 10; CAS-no. 71302-83-5 (Hydrocarbons, C9- unsaturated, polymerized)
- Composition of test material, percentage of components: see Section 1.2 Composition
- Lot/batch No.: 28724
- Stability under test conditions: no measured data; based on chemical structure assumed to be stable
- Storage condition of test material: room temperature, exclusion of light

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic
- Age at study initiation: no data, adult
- Weight at study initiation: 289 - 345 g (m); 203 - 238 g (f);
- Fasting period before study: no
- Housing: 1 animal/plastic cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12


Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: about 6 x 6 cm
- % coverage: aprox. 10% of the body surface
- Type of wrap if used: mull and plaster (strapping)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 h


Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body weight: before application, 8th and 15th day of study
Mortality: daily
Clinical signs: daily
Pathological examination: 15th day of study
- Necropsy of survivors performed: yes
Statistics:
not applicable

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
after 3 h: piloerection in 9/10 animals, single cases with decreased response to stimuli;
after 2 d: no particular findings
Body weight:
males: normal
females: transient decrease in body weight or decreased increments in weight gain from day 0-8 in 2/5 and 3/5 animals, respectively, normal at day 15 in all animals
Gross pathology:
no particular findings

Any other information on results incl. tables

Table No. 1: Individual body weight of animals – 2000 mg/kg – males

Animal No.

Before application

8th day

15th day

Body weight gain (g)

day 0-8 day
p.a.

day 8-15
p.a.

1 (pre-test)

303.12

314.82

344.33

11.70

29.51

2

312.22

319.95

339.75

7.73

19.80

3

288.64

307.12

322.93

18.48

15.81

4

331.10

343.42

372.79

12.32

29.37

5

345.85

356.79

382.47

10.94

25.68

Average

316.19

328.42

352.45

12.23

24.03

Table No. 2: Individual body weight of animals – 2000 mg/kg – females

Animal No.

Before application

8th day

15th day

Body weight gain (g)

day 0-8
p.a.

day 8-15
p.a.

1 (pre-test)

202.76

198.41

218.00

-4.35

19.59

2

211.57

215.53

226.80

3.96

11.27

3

237.63

238.23

244.08

0.6

5.85

4

203.10

205.58

214.33

2.48

8.75

5

226.60

215.68

230.24

-10.92

14.56

Average

216.33

214.69

226.69

-1.65

12.00

The test substance, Novares TL 10, applied on skin at a dose 2000 mg/kg of animal weight did not cause death of animals.    

Clinical signs of intoxication (piloerection, decreased response to stimuli) were observed in all males and four females. Transient decreases in body weight of females were recorded during study. No macroscopic changes were diagnosed during pathological examination of the animals.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
according to Regulation (EC) 1272/2008 (CLP regulation) no classification required
Conclusions:
The test material 'Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised' (technical product TL 10) did not cause any mortality in an acute dermal toxicity test (OECD 402) at the limit concentration of 2000 mg/kg bw. The LC50 was determined to be > 2000 mg/kg bw.