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Toxicological information

Skin irritation / corrosion

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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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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.