Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1996-06-28 to 1996-08-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to Guidelines. Thia study also meets with GLP Regulations, 21 CFR, Part 58, July 1991.The study is the result of a structural analogue substance used as read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
other: Toxic Substance Control Act (TSCA), 40 CFR, Part 798, Subpart E, Specific Organ/Tissue Toxicity, Primary Dermal Irritation, Section 798, 4470, Juy, 1993
Deviations:
no
GLP compliance:
yes
Remarks:
Self certified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Description: yellow solid.
- Stability: Stable

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Test animals –
Species: Rabbit
Strain: New Zealand White
Weight/Age range: Betwwen 2.0 and 3.0 kg (10 to 12 weeks old) weighed to the nearest 10gm.
Source: Registered commercial breeder.

Acclimatisation period: At least 5 days under test conditions
Diet: Commercial rabbit ration ad libitum
Water: Tap water ad libitum
Housing: Individually housed
Environmental conditions
Temperature: 68 ±5 °F
Humidity: 30 - 70 %
Air changes: 10 - 15 per hour
Photoperiod: 12-hour light/dark cycle, full spectrum fluorescent

Test system

Type of coverage:
other: A bandage was used to keep the test substance in contact with the skin. No data has been provided on whether it was semi-occlusive or occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
The test substance (0.5 grams) was applied to each application site. Seperate animals were not required for an untreated control group.
Duration of treatment / exposure:
Four hours
Observation period:
72 hours
Number of animals:
Six rabbits (3 male and 3 female)
Details on study design:
24 hours prior to test application, fur was removed from a group of 6 albino rabbits by clipping the skin of the trunk of the animals free of hair within 24 hours prior to application of the test substance. 0.5 g of the test substance was applied directly to each application site, and was secured using a bandage. 4 hours later, the bandage was removed.

Animals were observed for signs of erythema and edema at 30 - 60 minutes and then at 24, 48 and 72 hours after bandage removal. Observations were scored according to the Draize Scale for scoring skin reactions.

Animals were observed daily for mortality/clinical signs. Bodyweights were measured on day 0 and day 3.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 4 hours
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
No signs of erythema were noted at any of the observation periods. The test sites did not exhibit signs of oedema during the observation period.
Other effects:
No rabbits died during the course of the study. There were no overt signs of toxicity during the course of the study and all six animals exhibited a gain in body weight during the observation period.

Any other information on results incl. tables

 

Table 1: Animal weights and clinical observations.

 

 

Body Weight (Kg)

 

Animal #

Sex

Day 0

Day 3

Weight Change

Signs of Toxicity*

60905

Male

2.51

2.56

0.05

None

60906

Female

2.27

2.31

0.04

None

60907

Male

2.86

2.90

0.04

None

60908

Female

2.48

2.53

0.05

None

60909

Male

2.93

2.96

0.03

None

60910

Female

2.88

2.93

0.05

None

 

 

 

 

 

 

*Excluding erythema and edema observations at 30-60 minutes after the 4 hour exposure. 24, 48 and 72h

Table IIA: Draize scores

Animal#

30/07/96

4 Hours*

31/07/96

24 Hours

01/08/96

48 Hours

02/08/96

72 Hours

Total

Divided by 4

60905

0/0

0/0

0/0

0/0

0.0

60906

0/0

0/0

0/0

0/0

0.0

60907

0/0

0/0

0/0

0/0

0.0

60908

0/0

0/0

0/0

0/0

0.0

60909

0/0

0/0

0/0

0/0

0.0

60910

0/0

0/0

0/0

0/0

0.0

Primary Dermal Irritation Index (PDII) = 0.0

Note: PDII equals sum for all animals divided by 6.

*taken 30-60 minutes after the 4 hour exposure treatment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
According to the established criteria and guidelines, the test substance is considered a non-irritant to the skin of New Zealand White rabbits.
Executive summary:

The Read Across test substance RA2 was tested for its dermal irrtancy potential.

6 albino rabbits (3/sex) were prepared by clipping the skin of the trunk free of hair. 24 hours later, 0.5 grams of test substance was applied in a single dose application to the skin of the rabbits for 4 hours.

No mortalities or clinical signs were seen. There was no evidence of erythema or oedema at any of the observation periods.

Based on these results, the test substance is considered not to be a skin irritant.