Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, acetone oxime-blocked

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-09-26 to 2011-10-24

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)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

1998

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2008

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(propan-2-ylidene)amino N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3,5-bis({1,3,3-trimethyl-5-[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)carbamate; (propan-2-ylidene)amino N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3-({1,3,3-trimethyl-5-[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]cyclohexyl}methyl)-5-({1,3,3-trimethyl-5-[2,4,6-trioxo-3,5-bis(3,3,5-trimethyl-5-{[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]methyl}cyclohexyl)-1,3,5-triazinan-1-yl]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)carbamate

EC Number:

600-028-9

Cas Number:

1001254-87-0

Molecular formula:

Exact identification is not feasible

IUPAC Name:

(propan-2-ylidene)amino N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3,5-bis({1,3,3-trimethyl-5-[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)carbamate; (propan-2-ylidene)amino N-(3,3,5-trimethyl-5-{[2,4,6-trioxo-3-({1,3,3-trimethyl-5-[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]cyclohexyl}methyl)-5-({1,3,3-trimethyl-5-[2,4,6-trioxo-3,5-bis(3,3,5-trimethyl-5-{[({[(propan-2-ylidene)amino]oxy}carbonyl)amino]methyl}cyclohexyl)-1,3,5-triazinan-1-yl]cyclohexyl}methyl)-1,3,5-triazinan-1-yl]methyl}cyclohexyl)carbamate

Test material form:

other: solid

Details on test material:

Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, acetone oxime-blocked of Evonik Degussa GmbH, batch 11-22-18 of 2011-06-28.
Purity: approx. 99.5 % blocked oligomers
Molecular weight distribution: Mn = 1000 g/mol, Mw = 1200 g/mol (GPC)

Test animals

Species:

rat

Strain:

other: Rattus norvegicus

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Strain: Rattus norvegicus CD / Crl: CD(SD)
- Sex, age and body weight range
5 males, 8 weeks old, 200 - 213 g
5 females, 9 weeks old, 200 - 220 g
- Controls: no
- Fasting period before study: 16 hours
- Diet: ad libitum, R10 special diet for rats, SSniff R
- Water: ad libitum, tab water
- Acclimation period: at least 5 days
- Housing: during the 14-day observation period animals were kept singly in MAKROLON cages (type III plus)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 15 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark
- Air changes (per hr): 15 per hour

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

- Method of administration:
The intact dorsal skin of the animals was shaved free of hair with a shaver . The site was situated on the animal´s back between the fore and hind
extremities and had an area of at least 5 cm x 6 cm (approx. 1/10 of body surface).
The test patch was occlusive. The test item was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and
secured with adhesive plaster strips on the application site for 24 hours.

Duration of exposure:

24 hours

Doses:

- 2000 mg/kg bw,
- administration volume 10 ml/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

EXAMINATIONS: 
- Clinical signs:  before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration
- Mortality: at least once daily
- Body weights: days 0, 7, and 14
- Post dose observation period: 14 days
- Macroscopic examination:  day  14 

Statistics:

not required

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no mortalities

Mortality:

No mortality was observed at 2000 mg/kg

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

Macroscopic examination did not reveal any changes.

Other findings:

No other findings

Any other information on results incl. tables

No further information

Applicant's summary and conclusion

Conclusions:

Based on the results of this study the dermal LD50 of test item was estimated to be > 2000 mg/kg in male and female rats.

Executive summary:

In this experiment the test item was examined for acute toxicity after a single dermal application to rats.

One dose level of 2000 mg/kg b.w. was employed (limit test).

Under the present test conditions, a single dermal application of 2000 mg test item/kg b.w. to rats did not reveal any clinical signs of toxicity. No influence on animal behaviour or premature death was noted. The body weight gain was not influenced by the test item administration. No skin reactions were observed at the application site.The macroscopic examination did not reveal any changes.

Based on the results of this study the dermal LD50 of test item was > 2000 mg/kg in male and female rats.