PDI oligomers, isocyanurate (3x)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 January 2017 - 11 April 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987

Deviations:

yes

Remarks:

see 'Principles of method if other than guideline'.

Principles of method if other than guideline:

Occlusive coverage was used instead of semi-occlusive coverage (as recommended in OECD guideline 402).

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3,5-tris(5-isocyanatopentyl)-1,3,5-triazinane-2,4,6-trione

Cas Number:

119934-71-3

Molecular formula:

C21 H30 N6 O6

IUPAC Name:

1,3,5-tris(5-isocyanatopentyl)-1,3,5-triazinane-2,4,6-trione

Constituent 2

Reference substance name:

2-methylpropyl N-(5-isocyanatopentyl)-N-(5-isocyanatopentylcarbamoyl)carbamate

Molecular formula:

C18 H30 N4 O5

IUPAC Name:

2-methylpropyl N-(5-isocyanatopentyl)-N-(5-isocyanatopentylcarbamoyl)carbamate

Test material form:

liquid: viscous

Details on test material:

Appearance: colourless or light yellow viscous liquid
Storage conditions: at room temperature, container tightly closed, flushed with nitrogen.

Test animals

Species:

rat

Strain:

other: Crl: CD(SD), SPF animal

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc., Atsugi Breeding Center, Japan
- Age at study initiation: 7 weeks old
- Weight at study initiation: males: 251-284 g, females: 204-239 g
- Housing: polycarbonate flat-bottomed cages (W260 x D420 x H180 mm) with pulp bedding
- Diet: Pellet diet MF (Lot No. 161021; Oriental Yeast Co., Ltd.) was offered ad libitum
- Water: municipal tap water filtered through a 5-µm cartridge filter and sterilized with an ultraviolet sterilizer was offered ad libitum through an automatic water-supply system.
- Acclimation period: for 6 days after receipt

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.3°C - 24.7 °C
- Humidity (%): 35.8% - 63.2%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 18 January 2017 To: 1 February 2017

Administration / exposure

Type of coverage:

occlusive

Vehicle:

corn oil

Remarks:

(Sigma-Aldrich Corp.; Lot No. U5429)

Details on dermal exposure:

TEST SITE
- Area of exposure: 4 cm x 5 cm
- Application method: dosing material impregnated into a piece of lint was applied to the application site occlusively with non-permeable adhesive tape for 24 hours. It was secured with stretch adhesive bandage for contact improvement.

REMOVAL OF TEST SUBSTANCE
- Washing: after patch removal with distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 10 mL/kg body weight
- Constant volume or concentration used: yes

VEHICLE
- Amount applied: 8.003 g of test substance in 40 mL corn oil
- Concentration: 20-w/v%
- Lot no.: U5429
- Purity: not indicated

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations (general condition): On day 0: within 30 minutes of application, and subsequently at 1,2,3,4, and 6 hours after initiating application. On the following days (day 1-14) observations were performed daily.
- Frequency of weighing: Before application, on the day of application (day 0) and on day 1, 2, 3, 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No male or female died in either the control or test substance group.

Clinical signs:

other: No abnormalities were noted in either sex for the control group as well as for the test-substance group.

Gross pathology:

No abnormalities were noted in either sex in the control group as well as in the test-substance group.

Other findings:

There was no indication of skin irritation up to the relevant limit dose level.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute dermal toxicity study performed according to OECD guideline 402 and GLP principles, the acute dermal LD50 of STABiO D-376N was found to exceed 2000 mg/kg body weight. Based on these findings, the substance is not classified under GHS.

Executive summary:

In an acute dermal toxicity study, performed according to OECD guideline 402 and GLP principles, STABiO D-376N was tested in 5 female and 5 male rats per dose group. Both the control and the test-substance groups consisted of 5 each of female and male. The test material was prepared as a 20 w/v% formulation, using corn oil as a vehicle. The study was conducted at a limit dose of 2000 mg/kg body weight. The test material was applied occlusively for 24 hours. Mortality and general condition were monitored for 14 days after application. No female or male died in either group and no abnormalities were noted during the in-life phase and during gross pathology. Body weights increased satisfactory after decreasing in the first 3 days after application (test-substance group), and the gain for the 14 day period was normal. Based on these results, the LD50 was determined to be >2000 mg/kg body weight and STABiO D-376N is not classified under GHS.