Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-02-28 to 2012-03-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Name of test material: Trimethylolpropanepoly(oxypropylene)triamine
EC no.: 500-105-6
CAS no.: 39423-51-3
Physical state: clear colourless liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 1L708

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temp (21-26°C)

OTHER SPECIFICS:
- Analytical purity: Certificate of Analysis was provided by the Sponsor. No additional analysis was performed.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Millbrook Breeding Labs
- Age at study initiation: 19 weeks
- Weight at study initiation: 3.3 - 3.5 kg
- Housing: individually
- Diet (e.g. ad libitum): access to PMI certified Hi Fiber Rabbit diet
- Water (e.g. ad libitum): ad libitum via an automatic watering device
- Acclimation period: minimum of 5 days prior dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 °C
- Humidity (%): 36 - 63 %
- Photoperiod (hrs dark / hrs light): 12h light / 12h dark

IN-LIFE DATES: From: 28 Feb 2012 To: 9 Mar 2012

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
3 minutes, 1 hour, 4 hours
Observation period:
10 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 5 cm x 5 cm
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test article was removed using water and gauze

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 30-60 min, 24h, 48h, 72h after exposure
Score:
1.7
Max. score:
8
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: after 4h exposure
Irritation parameter:
erythema score
Basis:
animal: 646M
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: after 4 h treatment
Irritation parameter:
erythema score
Basis:
animal: 647M
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: after 4h treatment
Irritation parameter:
erythema score
Basis:
animal: 648M
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: after 4h treatment
Irritation parameter:
edema score
Basis:
animal: 646M
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: after 4h treatment
Irritation parameter:
edema score
Basis:
animal: 647M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: after 4h treatment
Irritation parameter:
edema score
Basis:
animal: 648M
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: after 4h treatment
Irritant / corrosive response data:
After 3 min exposure, the following is observed: very slight erythema without edema observed starting on day 3. Flaking of the skin observed on day 7. After 60 min exposure, the following is observed: well-defined erythema without edema observed starting on day 3. Flaking of the skin observed starting on day 8. After 60 min exposure, the following is observed: well-defined erythema and/or very slight edema observed starting at 24h post unwrap. Flaking of the skin observed starting on day 6.
Other effects:
No mortality is observed.
No clinical signs were recorded.

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Conclusions:
The substance is found to be a mild irritant (cat 3). The primary irritation index was 1.7.