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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive application
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: males: 45 and 46 months; female: 46 months
- Weight at study initiation: males: 2.41 and 2.97 kg; female: 3.07 kg
- Housing: 1 animal/cage in stainless steel cages with grating floor
- Diet: approx. 120 g/animal/day, Standard diet, ssniff K-Z, complete diet for rabbits - breeding (ssniff Spezialdiäten GmbH, Soest, Germany)
- Water: tap water, ad libitum
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.0-20.0
- Humidity (%): 48 - 92
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 11 Nov 1997 To: 02 Dec 1997

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
other: control site on the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g

VEHICLE
- Amount(s) applied: 0.2 mL

Duration of treatment / exposure:
4 hours
Observation period:
Duration of the observation period: 3 or 14 days after application
Reading time points: 1, 24, 48, 72 hours after removal of the patches, thereafter once daily
Number of animals:
Total number of animals: 3
2 males and 1 female
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: 1. cellulose fabric coated with natural rubber 2. synthetic film glue

REMOVAL OF TEST SUBSTANCE
- Washing: After the end of exposition time remaining test substance was gently washed off as far as possible
- Time after start of exposure: 4 hours


SCORING SYSTEM:
Draize Scoring Index

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 9 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
One animal showed very slight erythema (grade 1) one hour after patch removal until day 1 and very slight edema (grade 1), which subsided within 24 hours.
In the second animal erythema was well defined or moderate to severe (grade 2-3) and was still present (grade 1) at the end of the 14-day observation period. In this animal also slight or moderate edema (grade 2-3) was noted until day 2 and thereafter the edema was very slight (grade 1) until day 8. In addition, in the same animal indentation up to 1 mm and brown discolouration of the application site were found until day 5 after removal of the patch. Eschar was formed from day 1 until day 5, started to peel off on day 6 and was no longer detected on day 11 of observation.
Neither erythema nor edema formation was noted in the third animal after patch removal and up to 3 days after application.
Other effects:
There were no systemic toxic effects after dermal application of the test substance.

Applicant's summary and conclusion

Interpretation of results:
other: not classified for hydrated form TMT 55; inconclusive for anhydrous TMT
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of this skin irritation study in the rabbit the test item TMT 55 was slightly irritating to the skin. However, the data is conclusive but not sufficient for classification of TMT 55. For anhydrous TMT, the available data on skin irritation/corrosion is inconlusive for classification.