Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 16 - June 15, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The in vivo test was carried out for the purpose of another regulation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

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

Constituent 1
Chemical structure
Reference substance name:
1,3,5-triisopropylbenzene
EC Number:
211-941-3
EC Name:
1,3,5-triisopropylbenzene
Cas Number:
717-74-8
Molecular formula:
C15H24
IUPAC Name:
1,3,5-tris(propan-2-yl)benzene
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch No. 6F11027000
- Expiration date of the lot/batch: 17. Nov. 2016
- Purity: 96%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: S & K-LAP Kft.(Hungary)
- Age at study initiation: Adult, 14 weeks old
- Weight at study initiation: 3038 - 3400 g
- Housing: Animals were housed individually in metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 20 days in first animal, 21 days in second and third animal

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15 air exchanges/hour by central air-condition system
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL of the unchanged test item

The untreated right eye served as the control
Duration of treatment / exposure:
The eyes of the test animals were not washed out.
Observation period (in vivo):
1, 24, 48 and 72 hours after the application.
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The eyes of the test animals were not washed out.

SCORING SYSTEM: Draize (1979) and OECD 405 (2012)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Remarks:
1 hour after the single application of test item into the eye of the rabbits, slight redness and chemosis occurred
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Remarks:
1 hour after the single application of test item into the eye of the rabbits, slight redness and chemosis occurred
Irritant / corrosive response data:
1 hour after the single application of test item into the eye of the rabbits, slight redness and chemosis occurred.
24 hours after treatment all animals was free of symptoms.
Other effects:
- One hour after treatment some hyperemic blood vessels (score 1) were observed in all animals. The swelling of the conjunctivae was different from normal (score 1) in animal No.: 1828.
- 24, 48, and 72 hrs after treatment, all animals were free of symptoms.
- No systemic toxicity was observed on the day of treatment or during the observation period.
- Signs of pain and distress were not observed in animals during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
according to EC 1272/2008 as amended
Conclusions:
In conclusion, test item 1,3,5-Triisopropylbenzene applied to the rabbits' eye mucosa caused slight conjunctival irritant effects which were fully reversible within 24 hours.
Executive summary:

The acute eye irritation study with test item 1,3,5-Triisopropylbenzene was performed in New Zealand White rabbits. The irritation effect of the test item was scoring according to the Draize method (Draize, 1959; OECD Guideline 405, 2012).

The test item was placed into the conjunctival sac of left eye of each animal. The untreated right eye served as control. 0.1 ml of the test item was used for the study, in a single dose. The eyes of the test animals were not washed out.

1 hour after the single application of test item into the eye of the rabbits, slight redness and chemosis occurred. 24 hours after treatment all animals was free of symptoms. The 24/48/72 hour mean cornea opacity score, iris score, and chemosis score was 0.00, 0.00, and 0.00, respectively.

During the study the control eyes of animals were symptom-free. No systemic toxicity was observed. The body weight of animals corresponded to their species and age. Sign of pain and distress as discharge was not observed in animals during the study.

The test item 1,3,5-Triisopropylbenzene applied to the rabbits' eye mucosa caused slight conjunctival irritant effects which were fully reversible within 24 hours.