Esterification products of acrylic acid and 4,4'-isopropylidenediphenol ethoxylated

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 May 2012 - 06 July 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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

Constituent 1

Reference substance name:

Esterification products of acrylic acid and 4,4'-isopropylidenediphenol ethoxylated

EC Number:

701-362-9

Molecular formula:

(C2 H4 O)x (C2 H4 O)y C21 H20 O4

IUPAC Name:

Esterification products of acrylic acid and 4,4'-isopropylidenediphenol ethoxylated

Details on test material:

SID Change
Previous CAS: 64401-02-1
Previous EC: 613-584-2

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 8 weeks old on the day of treatment
- Mean body weight at study initiation: the males had a mean body weight of 358 g (range: 348 g to 366 g) and the females had a mean body weight of 241 g (range: 223 g to 254 g)
- Fasting period before study: yes, during the night before treatment
- Housing: the animals were housed by five from the same sex and group in polycarbonate cages with stainless steel lids
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: for a period of 5 or 8 days before treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h.

IN-LIFE DATES: 19 June 2012 to 06 July 2012.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 10% of body surface, dorsal site
- Type of wrap if used: hydrophilic gauze pad + adhesive hypoallergenic aerated semi-occlusive dressing + restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Removal of dressing: 24h post-exposure
- Washing: at 24h post-exposure, with a moistened cotton pad.

Duration of exposure:

1 single exposure of 24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 females (group 1) and 5 males (group 2).

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight: just before treatment on day 1; then on days 8 and 15.
- Necropsy of survivors performed: yes (macroscopic).

Statistics:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No unscheduled deaths occurred during the study.

Clinical signs:

other: No clinical signs indicative of systemic toxicity were observed in any animals. No cutaneous reactions were observed in any animals.

Gross pathology:

Several up to 0.3 cm black discolored foci were noted in the lung of one male treated at 2000 mg/kg with Ethoxylated bisphenol A diacrylate.
A 0.3 cm black discolored area was also noted in the lung (left lobe) of one male in the same group.
Despite the incidence of this finding in the male group (2/5 rats affected), a relationship to treatment was considered to be doubtful. Such changes may indeed occur as agonic changes.

Other findings:

no

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 of the test item was higher than 2000 mg/kg in rats.

Executive summary:

The objective of this study was to evaluate the potential toxicity of the test item following a single dermal application to rats.

This study was performed according to the international guidelines (OECD No. 402 and Council Regulation No. 440/2008 of 30 May 2008, Part B.3) and in compliance with the principles of Good Laboratory Practice.

 

Methods

The test item was applied in its original form to the skin of five female then five male Sprague-Dawley rats at the dose-level of 2000 mg/kg. The application site was covered by a semi-occlusive dressing for 24 hours.

Each animal was observed at least once a day for mortality and clinical signs for 15 days. From day 2, any local reactions at the treatment site were also noted. Body weight was recorded on day 1 and then on days 8 and 15.

On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination.Macroscopic lesions were preserved in buffered formalin then destroyed at the finalization of the study report as no microscopic examination was performed.

 

Results

No unscheduled deaths and no clinical signs indicative of systemic toxicity were observed in any animals.

No cutaneous reactions were observed in any animals.

When compared to CiToxLAB France historical control data, a lower body weight gain was noted in 4/5 males and in 3/5 females between day 1 and day 8.

There were no macroscopic changes related to the test item treatment.

Conclusion

The dermal LD50 of the test item was higher than 2000 mg/kg in rats.

Therefore, the test item is not classified as toxic or harmful by dermal route according to the criteria of CLP Regulation.