1,3,5-triisopropylbenzene

Skin irritation / corrosion

Administrative data

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

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 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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.

Test system

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)

Results and discussion

In vivo

Results

Results 1

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

Results 2

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.

Applicant's summary and conclusion

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.