3,3-dimethylbutyne

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented study according to internationally accepted guidelines and GLP compliant

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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3,3-dimethylbutyne

EC Number:

213-035-3

EC Name:

3,3-dimethylbutyne

Cas Number:

917-92-0

Molecular formula:

C6H10

IUPAC Name:

3,3-dimethylbut-1-yne

Test material form:

gas under pressure: refrigerated liquefied gas

Details on test material:

Test item: 3,3-dimethylbutyne
CAS No. 917-92-0
Batch No. L37038N
Physical state Clear, transparent, liquid
Colour Colourless
Active ingredient content (GC) 97.5%
Storage 2-8°C in a tightly closed container

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Source: S & K-LAP Kft.
Hygienic level during the study: good conventional
Justification of strain: The New Zealand white rabbit is one of the standard animals in acute eye irritation study.
Number of animal: 3 males
Age of animals: adult rabbits, 24 weeks old
Body weight range at the beginning of the study: 4511 - 4958 g
Body weight range at the end of the study: 4540 - 4988 g
Acclimatisation time: 89 days in first animal, 90 days in second and third animal
Animal health: Only animals in acceptable health condition were used for the test.

Housing: Animals were housed individually in metal cage.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20 ± 3 °C
Relative humidity: 30-70 %
Ventilation: 10-15 air exchanges/hour by central air-condition system

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The contralateral eye served as control.

Amount / concentration applied:

0.1 ml of the test item was used for the study in pure state, as a single dose.

Duration of treatment / exposure:

The eyes of the test animals were not washed out 24 hour after test item application, because the test item had been removed from the eye of test animal by physiological mechanisms.

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hours after the application.

Number of animals or in vitro replicates:

3 male

Details on study design:

In the first step an initial test was performed using one animal. The test item was placed into the conjunctival sac of the left eye. The eyelids were held closed gently for about one second to prevent any loss of the test item. The contralateral eye served as control.
In the initial test no irritant effect was observed 24 hours after the treatment. The confirmatory test was conducted using a second and third animal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

(opacity)

Basis:

mean

Time point:

other: 24, 48 and 72 hours after the treatment

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours after the treatment

Score:

0

Max. score:

0

Results 3

Irritation parameter:

other: redness (conjunctival)

Basis:

mean

Time point:

other: 24, 48 and 72 hours after the treatment

Score:

0

Max. score:

0

Results 4

Irritation parameter:

chemosis score

Remarks:

(conjunctival)

Basis:

mean

Time point:

other: 24, 48 and 72 hours after the treatment

Score:

0

Max. score:

0

Results 5

Irritation parameter:

other: conjunctival discharge

Basis:

mean

Time point:

other: 24, 48 and 72 hours after the treatment

Score:

0 - 0.33

Max. score:

0.33

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

Treated and control eyes were examined at 1, 24, 48 and 72 hours after the application. One hour after treatment some hyperemic blood vessels (score 1) of the conjunctivae were observed in two animals (No.: 7, 9). The amount of discharge of the conjunctivae was different from normal (score 1) in two animals (No.: 7, 8). 24 hours after treatment the amount of discharge of the conjunctivae was different from normal (score 1) in animal No.: 8. Two animals (No.: 7, 9) became free of symptoms. 48 hours after treatment all animals were free of symptoms. 72 hours after treatment all animals were free of symptoms.
72 hours after the treatment the study was finished.
During the study the control eyes of animals were symptom-free.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

In conclusion, test item 3,3-dimethyl-butyne (CAS No. 917-92-0) applied to the rabbits' eye mucosa caused conjunctival irritant effects which were fully reversible within 48 hours.
The test item can not be classified into any hazardous category.