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EC number: 211-941-3 | CAS number: 717-74-8
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:
- 2 015
- 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
- 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
Constituent 1
- 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
Resultsopen allclose all
- 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.
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.
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