Registration Dossier

Administrative data

Description of key information

No primary skin irritation symptoms, such as erythema and oedema, or other signs occurred during the observation period.

 

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.

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:
Mar 10 to Apr 1, 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
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
GLP compliance:
yes (incl. certificate)
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%
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: S & K LAP Kft., Hungary
- Age at study initiation: Adult
- Weight at study initiation: 2628-2734 g
- Housing: housed individually in metal cages
- Diet (e.g. ad libitum): CRLT/ny rabbit diet produced by Szindbád Kft., 2100 Gödöllő (Szárítópuszta)
- Water (e.g. ad libitum): Tap water
- Acclimation period: 6 days

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.
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: Test item was applied in pure state

NEGATIVE CONTROL
The untreated skin of each animal served as control
Duration of treatment / exposure:
4 hrs
Observation period:
60 minutes and then at 24, 48 and 72 hours after the patch removal
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: approximately 6 cm² area of intact skin
- Type of wrap if used: Sterile gauze pads (10x10cm) surrounded with adhesive hypoallergenic plaster. Entire trunks of the animals were wrapped with plastic wrap.

REMOVAL OF TEST SUBSTANCE
After 4 hours the rest of the test item was removed with water of body temperature

OBSERVATION TIME POINTS
60 minutes and then at 24, 48 and 72 hours after the patch removal

SCORING SYSTEM:
- Method of calculation: Draize (1959)
Irritation parameter:
erythema 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:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No primary irritation symptoms, such as erythema and oedema, or other signs occurred during the observation period.
Other effects:
During the study the general state and behaviour of animals were normal.
There were no notable body weight changes during the contact and observation period.
Interpretation of results:
GHS criteria not met
Remarks:
according to EC 1272/2008 as amended
Conclusions:
No primary irritation symptoms, such as erythema and oedema, or other signs occurred during the observation period.
Executive summary:

In this skin irritation study New Zealand White rabbits were treated with the test item 1,3,5 Triisopropylbenzene. The test item was applied to the intact skin of rabbits in a single dose of 0.5 ml. The irritation symptoms were examined at 1, 24, 48 and 72 hours after patch removal.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.00 and 0.00 respectively. During the study the general state and behaviour of animals were normal. There were no notable body weight changes during the contact and observation period.

No primary irritation symptoms, such as erythema and oedema, or other signs occurred during the observation period.

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:
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
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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%
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.
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)
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.
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.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Skin corrosion/irritation:

No primary irritation symptoms, such as erythema and oedema, or other signs occurred during the observation period following exposure to 100% test item. Therefore, according to EC 1272/2008 as amended, the test substance does not meet the criteria for skin corrosion/irritation classification.

 

Serious eye damage/eye irritation

The 24/48/72 hour mean cornea opacity score, iris score, and chemosis score was 0.00, 0.00, and 0.00, respectively following exposure to 100% test item. Therefore, according to EC 1272/2008 as amended, the test substance does not meet the criteria for serious eye damage/eye irritation classification.