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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:
06 Mar 1992 - 23 Dec 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
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: Thomae, Biberach, Germany
- Weight at study initiation: 2.19 ± 0.187 kg
- Housing: singly in wire mesh cages
- Diet (e.g. ad libitum): Altromin K, Type 2123, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Quarantine: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 45-65%
- Air changes (per hr): 12-15 /h
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 1992-07-28 To: 1992-08-18

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
14 days
Number of animals:
6 males
Details on study design:
TEST SITE
- Area of exposure: left or right of dorsal midline
- coverage: 2 x 3 cm gauze patch
- Type of wrap if used: fixomull

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
0.5, 1, 6, 24, 48, 72 h; Days 4, 7, 10, and 14

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.72
Max. score:
3
Reversibility:
fully reversible within: Day 14
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: Day 10
Irritant / corrosive response data:
see table below

Any other information on results incl. tables

Rabbit # Time [h] Erythema Oedema
1 24 2 0
  48 2 0
  72 2 0
  average 2.0 0.0
2 24 1 0
  48 2 2
  72 1 2
  average 1.3 1.3
3 24 1 0
  48 3 0
  72 2 0
  average 2.0 0.0
4 24 1 0
  48 2 0
  72 1 0
  average 1.3 0.0
5 24 1 0
  48 1 0
  72 1 0
  average 1.0 0.0
6 24 2 0
  48 3 0
  72 3 0
  average 2.7 0.0
Time [h] Erythema Oedema
average 24 1.33 0.00
score 48 2.17 0.33
72 1.67 0.33
24+48+72 1.72 0.22

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
DMPT is mildly irritating to skin, but does not meet the CLP criteria for classification as a skin irritant.