Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol

Acute Toxicity: dermal

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol

EC Number:

700-960-7

Cas Number:

68512-30-1

Molecular formula:

not applicable

IUPAC Name:

Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol

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 or test system 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 levels

Effect levels 1

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

Effect levels 2

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:

other: 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.

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 12^thday 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