Registration Dossier

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Administrative data

Description of key information

Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, acetone oxime-blocked is not irritating to skin (NOTOX B.V., 2001, 2001). The test substance is slightly irritating to eyes (NOTOX B.V., 2001), which do not meet criteria according to EC Regulation 1272/2008 to be classified as "irritating to eyes".

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001-05-22 - 2001-05-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Directive 92/69/EEC, B.4
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS: 
- Source: Charles River Deutschland (Germany)
- Sex: male
- Age: at least 6 weeks old
- Controls: untreated skin surrounding the application area
- Diet: ad libitum, Altromin special diet for rabbits
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark
- Air changes (per hr): 15 per hour
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 g test substance, moistened with 0.8 ml vehicle
Duration of treatment / exposure:
4 hour(s)
Observation period:
Postexposure period: 72 hours (Because no effects have been observed the period of observation is not 14 days but 72 hours.)
Number of animals:
3 males
Details on study design:
ADMINISTRATION/EXPOSURE
- Area of exposure: dorsal area of trunk, shaved 24 hours in advance,  approx. 10 x 15 cm2
- Vehicle: water
- Preparation of test substance: fine grinding in mortar, 500 mg test substance was moistened with 0.8 ml water to ensure close contact with skin
- Occlusion: metalline patch (2x3 cm) held in place by semi-occlusive non-irritating  tape dressing
- Duration: 4 h , after application was removed, skin was cleaned with water
EXAMINATIONS
- Examination time points: 60 minutes, 24, 48, and 72 hours after patch removal
- Scoring system: Draize (0-4 possible scores each for erythema/eschar  and for edema)
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 60 min, 24 hrs, 48 hrs, 72 hrs
Score:
0.17
Max. score:
8
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0.22
- Edema: 0
REVERSIBILITY: fully reversible within 72 h
Other effects:
Under the test conditions one of the three rabbits showed very slight erythema between 24 and 48 hours.

no other information

Conclusions:
Under the test conditions one of the three rabbits showed very slight erythema between 24 and 48 hours. Therefore, the test item is not irritating to skin.
Executive summary:

The acute skin irritation properties of the test item were estimated according to OECD Guideline 404.

A dose of 500 mg test item per animal was applied to the shaved, intact dorsal skin of 3 male rabbits under semi-occlusive conditions. After the 4 -hour exposure period the patch was removed and the resulting reactions were examined.

The average scores at 60 min, 24, 48 and 72 hours after patch removal are as follows: one of the three rabbits showed very slight erythema between 24 and 48 hours.

Therefore, the test item is not irritating to skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001-05-28 - 2001-05-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: 
- Source: Charles River Deutschland (Germany)
- Sex: male
- Age: at least 6 weeks old
- Controls: untreated eye
- Diet: ad libitum, Altromin special diet for rabbits
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark
- Air changes (per hr): 15 per hour
Vehicle:
unchanged (no vehicle)
Controls:
other: identical animal, left eye
Amount / concentration applied:
undiluted, test substance was grounded to a powder using a mortar
Amount applied: 0.82 mg, a volume of approximately 0.1 ml/animal
Duration of treatment / exposure:
not rinsed; no removal of test substance
Observation period (in vivo):
1, 24, 48 and 72 hours after administration
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
- not rinsed
- Ophthalmoscopic examination with a slit lamp: prior to the administration and 1, 24, 48 and 72 hours after administration; 24 hours after
administration, the eyes were treated additionally with fluorescein and examined.
- Scoring system: Draize
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.78
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0.0
- Iris: 0
- Conjunctivae (Redness): 0.78
- Conjunctivae (Chemosis): 0.11
Other effects:
There were no systemic intolerance reactions.

no further remarks

Conclusions:
Under the conditions of this study the test item showed only slightly eye irritating effects in rabbits.
Executive summary:

A study was performed to examine eye irritating effects of test item according to OECD TG 405.

An amount of 0.82 mg was instilled into the conjunctival sac of the right eye of each of three male rabbits, and the untreated left eye served as control.

Observations were made 1, 24, 48 and 72 hours after instillation.

Under the present test conditions, test item caused the following effects: The iris and conjunctivae was not effected after instillation of the test substance. Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 72 hours. There were no systemic intolerance reactions.

Therefore, under the conditions of this study test item showed only slightly eye irritating effects in rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, acetone oxime-blocked is not irritating to skin of rabbits (OECD 404; NOTOX B.V., 2001, 2001). The test substance is slightly irritating to eyes in rabbits (OECD 405; NOTOX B.V., 2001), which do not meet criteria according to EC Regulation 1272/2008 to be classified as "irritating to eyes".


Justification for selection of skin irritation / corrosion endpoint:
Only one study available.

Justification for selection of eye irritation endpoint:
Only one study available.

Justification for classification or non-classification

Based on the assessment of two animal studies (skin and eye irritating) and according to criteria of EC Directive 67/548/EEC and EC Regulation 1272/2008 cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, acetone oxime-blocked is not irritating to skin and eyes. Therefore, the test substance must not be classified.