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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:
10 Oct 2016 - 31 March 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted in accordance with international guidelines and in accordance with GLP. All relevant validity criteria were met.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2018

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 material form:
solid
Details on test material:
Storage Conditions:Stable at ambient temperature (10-30°C). Store in darkness; may be used/formulated in light.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance Research Product Inc, Denver, PA
- Females (if applicable) nulliparous and non-pregnant:Not stated
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 2.8 - 2.9 kg
- Fasting period before study: not specified
- Housing: individually housed in suspended wired-bottom cages, absorbent paper was changed at least three times per week.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet No. 5321)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not stated
- Humidity (%): Not stated
- Air changes (per hr): Not stated
- Photoperiod (hrs dark / hrs light): 12 : 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: Corn oil
Remarks:
test item was moistened with 0.5 ml of corn oil
Controls:
no
Amount / concentration applied:
0.5 g per site
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 & 72 hours
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.4
Max. score:
4
Reversibility:
other: Absent
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Absent
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Absent
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Absent
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Absent
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Absent
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Absent
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
DOT: Not corrosive

Any other information on results incl. tables

Table 3. Results and Discussion

No. of animals

Dermal Responses(Timing post- exposure)

Erythema

Edema

Additional Observations

Three Minutes Exposure

1

0 Minute

Absent

Absent

None

60 Minutes

Absent

Absent

None

One Hour Exposure

2

1-hour

Absent

Absent

None

24-hour

Absent to very slight

Absent

None

48-hour

Absent

Absent

None

72-hour

Absent

Absent

None

Four Hours Exposure

3

1-hour

Very slight

Absent to very slight

None

24-hour

Absent

Absent

None

48-hour

Absent

Absent

None

72-hour

Absent

Absent

None

Systemic Observation

No abnormal physical signs were observed among all three animals.

 

Body weight

Two animals gained weight and one study animal lost weight by study termination.

 

Conclusions

Primary Irritation Index (PII) =0.4Response Category:Practically Non-irritating (Negligible)

DOT:Not corrosive, NoEPA:NotGHS:Not packing group assignment Classified Classified

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the consition of the study, the primary irritation index (PII) of the test item was 0.4, following exposure to clipped rabbit skin under semi-occlusive condition. The test item does not meet the criteria for classification according to the Globally Harmonized Classification System and to the Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixture.
Executive summary:

OECD 404 (2016) -the irritant or corrosive effects of the test article was assessed following application to the clipped skin of white New Zealand rabbit. The test article (0.5 g) was applied dermally to Site 1 for exposure period of 3 minutes under occlusive patch. Since the reaction of the initial animal did not produce a corrosive or severely irritating effect, two additional animals (one female and one male) were added to the study. All three animals were dosed at Site 2 for an exposure period of one hour and Site 3 for an exposure period of four hours. Erythema and edema were scored at 1, 24, 48 and 72 hours after patch removal for the one and four-hour exposures. Animals were observed for mortality, toxicological and pharmacological effects at least once daily. Body weights were recorded pre-test and at termination.

No abnormal physical or systemic signs were observed among all three animals. Two animals gained weight and one study animal lost weight by study termination. No mortality reported.

Very slight erythema and oedema was noted within 24 hours post exposure and it was fully reversible. The Primary Irritation Index (PII) of theist item was reported as 0.4.

Under the condition of the study, it was concluded that test item was not corrosive and does not cause irritation to the rabbits’ skin. Therefore, the test item does not meet the criteria for classification according to the Globally Harmonized Classification System and to the Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixture.