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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19. 10. – 05. 11. 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

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 LA 300
- Substance type: organic
- Test material is 'Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol' (OAPP), EC list number 700-960-7 (assigned manually to validated substances from inquiries by ECHA). Originally the substance phenol, methylstyrenated, CAS No. 68512-30-1, EC No. 270-966-8 was submitted for registration. Subsequent to substance validation, the identity of the substance was changed by ECHA.
- for additional information see respective study record
Specific details on test material used for the study:
- Name of test material (as cited in study report): Novares LA 300 (phenol, methylstyrenated)
- Lot/batch No.: 28166
- Composition of test material: composition is specified in IUCLID Sect. 13 - Assessment reports under Certificate of Analysis_Novares LA 300_phenol, methylstyrenated- 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: 278 - 317 g (m); 203 - 223 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.
Remarks on result:
other: Novares LA 300
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Novares LA 300
Mortality:
none
Clinical signs:
after 3 h: piloerection in 9/10 animals, single cases with red secretion around eyes and decreased response to stimuli;
after 2 d: no particular findings, but 1 female with skin irritation which healed by day 11.
Body weight:
males: normal
females: transient decrease from day 0-8 in 4/5 animals, normal at day 15 in 4/5 animals
Gross pathology:
no particular findings, but 1 female with discoloration of the liver (light colour)

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
p.a.

day 8-15
p.a.

1 (pre-test)

298.75

317.19

340.74

18.44

23.55

2

278.31

298.94

313.65

20.63

14.71

3

304.74

317.66

345.98

12.92

28.32

4

316.89

332.24

354.09

15.35

21.85

5

303.66

311.04

330.31

7.38

19.27

Average

300.47

315.41

336.95

14.94

21.54

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)

223.08

219.18

231.28

-3.90

12.1

2

223.42

216.23

223.05

-7.19

6.82

3

217.08

226.69

232.16

9.61

5.47

4

203.13

200.73

214.09

-2.40

13.36

5

204.65

200.79

204.00

-3.86

3.21

Average

214.27

212.72

220.92

-1.55

8.19

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

Clinical signs of intoxication (piloerection, decreased response to stimuli, red secretion around eyes) were observed in all males and four females. Irritation on the skin was observed after application of the test substance in one female. Symptoms of irritation faded away on 12thday after application of the test substance. Decreased body weight in females was recorded in period day 0-8 of the study. Macroscopic changes were diagnosed during pathological examination in one female (liver – light colour).

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
no classification required