Amino functional alkoxysilanes

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, France
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2.4-2.6 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 'Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study. '

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10-14
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

The skin reactions were assessed at ca. 1, 24, 48 and 72 hours as well as 7, 10 and 14 days after the removal of the gauze patch and test item.

Number of animals:

1 male, 2 females

Details on study design:

TEST SITE
- Area of exposure: left flank
- coverage: 10 x 10 cm
- Type of wrap if used: surgical gauze patch, covered with semi-occlusive dressing which was then wrapped around the abdomen and anchored with tape

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

SCORING SYSTEM: The skin reaction was assessed according to te numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 (based on teh Draize score system)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 24 h

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Application of the test item to healthy intact rabbit skin resulted in a primary irritation index of 1.33. Local signs (mean values from 24 to 72 hours) consisted of grade 1.22 erythema and grade 0.11 oedema. Very slight to well defined erythema was observed in all animals 1 hour after treatment and persisted in two animals up to the 48 hour reading and in the other animal up to the 72 hour reading. Very slight swelling at the test site was noted in one female 1 hour after the treatment and in the other female 24 hours after treatment. Slight scaling of the skin at the test site was evident in the male at the 72 hour reading. In addition, the skin of this animal was noted to be dry and inelastic from 24 to 72 hours after treatment. Slight to moderate scaling at the test site was also noted in both the females from 7 to 10 days or from 72 hours to 10 days after treatment. The skin of these two female animals was similarly noted to be dry and inelastic from 48 to 72 hours or from 24 to 72 hours after treatment. All skin reactions had cleared within 14 days of treatment. No staining by the test item of the treated skin was observed. No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Other effects:

No clinical signs or systemic toxicity were observed in the animals during the study and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the in vivo skin irritation study with N-ethyl-3-trimethoxysilyl-2-methyl-propanamine, conducted according to OECD Test Guideline 404 and in compliance with GLP, the test substance was concluded to be not irritating to rabbit skin.