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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:
From July 05 to 08, 2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
systemic effects not followed; animals not weighed at the end of the study
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Clear colourless liquid
Details on test material:
- Name of test material (as cited in study report): TMPTMA
- Physical state: Clear colourless liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: Individually housed in suspended cages
- Diet (e.g. ad libitum): Certified Rabbit Diet (Code 5322) (BCM IPS Limited, London, UK), ad libitum
- Water (e.g. ad libitum): Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hour): 15/hour
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
Three males
Details on study design:
TEST SITE
- Area of exposure: Dorsal flank area
- Type of wrap if used: Test material (0.5 mL) was applied beneath a gauze (2.5 cm X 2.5 cm), placed directly on the test sites and then secured in position with surgical adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
for each animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
for each animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
- Very slight erythema was observed at the application sites which subsided within 24 hours
- See table 1 for individual animal scores
Other effects:
No

Any other information on results incl. tables

Table 1: Individual skin reactions

Rabbits No.

62 Male

63 Male

64 Male

Erythema/Eschar

1 hour

1

1

1

24 hours

0

0

0

48 hours

0

0

0

72 hours

0

0

0

Mean (24 hours + 48 hours + 72 hours)

0

0

0

Oedema

1 hour

0

0

0

24 hours

0

0

0

48 hours

0

0

0

72 hours

0

0

0

Mean (24 hours + 48 hours + 72 hours)

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
not skin irritating
Conclusions:
Under the test conditions, TMPTMA is not classified as irritating to the skin according to the CLP Regulation (EC) N° (1272-2008).
Executive summary:

In a primary dermal irritation GLP study performed according to OECD guideline 404, three New-Zealand white male rabbits were dermally exposed to 0.5 mL of TMPTMA, under a semi-occlusive bandage (25 cm X 25 cm) for 4 hours to clipped skin of dorsal flank area. Animals then were observed for 72 hours. Irritation was scored by the method of Draize (1959).

Very slight erythema was observed at the application sites which subsided within 24 hours. Mean individual scores at 24, 48 and 72 hours after removal of the test material for the 3 animals were 0, 0, 0 for erythema/oedema score. In this study, TMPTMA is not a dermal irritant on male rabbits.

Under the test conditions, TMPTMA is not classified as irritating to the skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).