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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: granular
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 6X07A106
- Expiration date of the lot/batch: May 16, 1997

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient temperature

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test substance was dispersed in cold water, then heated to 80 degrees C for 10 minutes. Test solutions were stored at 4 degrees C.
- Final dilution of a dissolved solid, stock liquid or gel: 3% and 20% dilution in water

FORM AS APPLIED IN THE TEST (if different from that of starting material): solution

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Broekman Instituut B.V.
- Age at study initiation: young adult
- Weight at study initiation: 1500-1900 g

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 3% and 20%

Duration of treatment / exposure:
4 hrs
Observation period:
72 hrs
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm area on each side of backs and flanks
- Type of wrap if used: Test solutions were placed on a patch which were fixed to the animals with adhesive tape, and the trunks then wrapped with impervious material.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hrs

OBSERVATION TIME POINTS
1, 24, 48, and 72 hrs after exposure

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 3% solution
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 3% solution
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: 20% solution
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
other: 20% solution
Irritant / corrosive response data:
One animal in the 20% group showed minor signs of redness at the 24-hr observation. This animal showed no signs of irritation at subsequent observations. No other signs of irritation were noted in any other animal in either group.

Any other information on results incl. tables

Skin Irritation Scores

Mean Score

1 hr

24 hrs

48 hrs

72 hrs

Erythema
3% Exposure

0

0

0

0

Edema
3% Exposure

0

0

0

0

Erythema
20% Exposure

0

0.5

0

0

Edema
20% Exposure

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LMD is not irritating to skin at concentrations of up to 20%.
Executive summary:

Three animals were exposed to solutions of 3% and 20% LMD for 4 hrs. After 4 hrs, the test substance was removed. The animals were observed for signs of irritation at 1, 24, 48, and 72 hrs after removal. Only minor irritation was seen in one animal at the 24 hr observation. The irritation was fully reversible by 48 hrs. LMD is therefore not irritating to the skin at concentrations of up to 20%.