Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide

Acute Toxicity: dermal

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

Study period:

31 January to 21 February 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study on analogue substance conducted to GLP and OECD test guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide

EC Number:

903-161-3

IUPAC Name:

Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide

Test material form:

liquid: viscous

Details on test material:

- Material tested was a sample of 100% EC-903-161-3 diluted in base oil.
- Name of test material (as cited in study report): EC-903-161-3
- Physical state: Dark brown/black viscous liquid
- Lot/batch No.: LN09010643
- Expiration date of the lot/batch: 19 December 2013
- Storage condition of test material: Ambient temperature, in the dark

The material was condisered suitable for read across to EC 903-162-9, the justification for this read across is provided in IUCLID section 13.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River UK, Margate
- Age at study initiation: 8 to 10 weeks old
- Weight at study initiation: 202 and 236 g (males) and 199 and 250 g (females)
- Fasting period before study: Not applicable
- Housing: Singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 22°C on each day
- Humidity (%): Approximately 32% to 49%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs dark, 12 hrs light

IN-LIFE DATES: From: To: 31 January to 21 February 2012

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: ~21 cm2 (males) and ~38 cm2 (females)
- % coverage: ~7% (males) and ~12% (females)
- Type of wrap if used: Micropore and Sleek tape

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.44 mL (males) and 0.45 mL (females)
- Concentration (if solution): NA
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

2370 mg/kg (The selected dose level for this study was 2000 mg/kg. The Sponsor stated that the test item density was
1.185 kg/L. Because the density was not used to calculate the administered dose volumes, the actual dose
level was 2370 mg/kg).

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At least 5 times on the day of dosing and once daily from Day 2 to Day 15
- 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:

> 2 370 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths among animals treated with EC-903-161-3 at 2370 mg/kg.

Clinical signs:

other: There were no signs of systemic toxicity in any animal at any observation timepoint. Clinical signs were restricted to test item residues at the test site, which was seen in all animals on Day 2 only.

Gross pathology:

There were no abnormal findings noted at necropsy.

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 the study, the median lethal dermal dosage (LD50) for EC-903-161-3 in Sprague-Dawley rats was estimated to be greater than 2370 mg/kg. This study is considered to be relevant, reliable and adequate for risk assessment and for classification purposes for EC 903-162-9.

Executive summary:

The objective of this OECD 402 study was to assess the adverse effects which can follow within a short period of time after a single dermal administration of EC-903-161-3 to rats.

The test item was administered to a single group of 5 male and 5 female Sprague-Dawley rats. The study design was as follows:

Text Table1
Experimental Design

Dose Level (mg/kg)	Dose Volume (mL/kg)	Animal Numbers
		Males	Females
2370	2	1 to 5	6 to 10

 

The selected dose level for this study was 2000 mg/kg. The Sponsor stated that the test item density was 1.185 kg/L. Because the density was not used to calculate the administered dose volumes, the actual dose level was 2370 mg/kg.

 

The test item was administered, as supplied, onto the dorsal trunk under a gauze patch which was covered with semi-occlusive tape, then secured with occlusive tape (iethe site was fully occluded). The dressings remained in place for 24 h. The dose was calculated on the basis of the body weights of the animals on the day of dosing. Animals were observed for signs of reaction to treatment a minimum of 5 times on the day of dosing. Thereafter animals were observed once daily from Day 2 until the end of the observation period on Day 15. Body weights were recorded weekly and all animals were subjected to a necropsy examination.

The following parameters and end points were evaluated in this study: clinical signs, body weights, body weight changes, and gross necropsy findings.

There were no unscheduled deaths during the observation period.

There were no systemic signs of toxicity noted in any animal at any observation timepoint and local findings at the dosing site were restricted to test item residues at the test site, which was seen in all animals on Day 2 only.

Body weight gain was considered to be acceptable for rats of this age and strain. No abnormal findings were noted at necropsy.

Under the conditions of the study, the median lethal dermal dosage (LD₅₀) for EC-903-161-3 in Sprague-Dawley rats was estimated to be greater than 2370 mg/kg.

The study is being used as read across from EC 903-161-3 to EC 903-162-9. The justification for this read across is provided in IUCLID section 13.