Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: . ca. 5 months
- Weight at study initiation: 3.3 - 3.8 kg
- Housing: 1 /cage in suspended wire cages
- Diet: Fresh PMI Rabbit Chow (Diet #5321), ad libitum
- Water: ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 and #2
Time point:
other: 24, 48 and 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Erythema was absent to barely perceptible at 60 minutes following patch removal, barely perceptible to well defined at 24 and 48 hours, well defined at 72 hours, barely perceptible to well defined on day 7 and absent by day 14.
Edema was barely perceptible to moderate at 60 minutes following patch removal, barely perceptible to well defined at 24 hours, absent to well defined at 48 and 72 hours, absent to barely perceptible on day 7 and absent by day 14.
Other effects:
There were no abnormal physical signs noted during the observation period.
One animal lest weight on day 7. Ali other body weight changes were normal.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Luperox XPS-TP is slightly irritant for the skin.
Executive summary:

The irritant or corrosive effects, if any, of Luperox XPS-TP when applied dermally was evaluated following OECD guideline no. 404. Three healthy New Zealand White rabbits (1 male - 2 females) were dosed dermally with Luperox XPS-TP. The test article (0.5 ml) was applied dermally to one intact site/rabbit. The test article was kept in contact with the skin for 4 hours at which time the wrappings were removed. Dermal reactions were scored at 60 minutes following patch removal. Reactions were scored again at 24, 48 and 72 hours and on days 7 and 14 following patch removal. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction at these time periods. Body weights were recorded pretest, 72 hours, day 7 and at termination. Erythema was absent to barely perceptible at 60 minutes following patch removal, barely perceptible to well defined at 24 and 48 hours, well defined at 72 hours, barely perceptible to well defined on day 7 and absent by day 14. Edema was barely perceptible to moderate at 60 minutes following patch removal, barely perceptible to well defined at 24 hours, absent to well defined at 48 and 72 hours, absent to barely perceptible on day 7 and absent by day 14. There were no abnormal physical signs noted during the observation period. One animal lost weight on day 7. All other body weight changes were normal. Luperox XPS-TP is slightly irritant for the skin.