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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-08-14 to 1991-08-14
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Qualifier:
according to guideline
Guideline:
other: The Japanese Regulations for the Carriage and storage of Dangerous Goods by Ships” Notification No. 623 of Ministry of Transport
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N,N',N'-tetramethyl-N''-[3-(trimethoxysilyl)propyl]guanidine
EC Number:
274-092-8
EC Name:
N,N,N',N'-tetramethyl-N''-[3-(trimethoxysilyl)propyl]guanidine
Cas Number:
69709-01-9
Molecular formula:
C11H27N3O3Si
IUPAC Name:
N,N,N',N'-tetramethyl-N''-[3-(trimethoxysilyl)propyl]guanidine
Constituent 2
Reference substance name:
N,N,N',N'-tetramethyl-N" -[3-(trimethoxysilyl)propyl]guanidine
IUPAC Name:
N,N,N',N'-tetramethyl-N" -[3-(trimethoxysilyl)propyl]guanidine
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
other: Japanese white rabbit
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: 12 weeks
- Weight at study initiation: 2.07 - 2.15 kg
- Housing: no data
- Diet: no data
- Water: no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied:0.5 ml


Duration of treatment / exposure:
4 minutes, 60 minutes, 4 hours
Observation period:
Assessment of reactions was carried out at 4 minutes, 60 minutes and 4 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 3 sites, not specified
- % coverage: no data
- Type of wrap if used: no data


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Erythema or oedema
Basis:
other: 3 animals
Time point:
other: 3 minutes
Score:
0
Max. score:
3
Reversibility:
no data
Remarks on result:
other: No erythema or oedema was observed in any animal at 3 minutes. No scoring system was used in this study.
Irritation parameter:
other: necrosis
Basis:
other: 3 animals
Time point:
other: 60 minutes
Score:
2
Max. score:
3
Reversibility:
no data
Remarks on result:
other: Necrosis was observed in two out of three animals at 60 minutes. No scoring system was used in the study.
Irritation parameter:
other: slight erythema
Basis:
other: 3 animals
Time point:
other: 60 minutes
Score:
1
Max. score:
3
Reversibility:
no data
Remarks on result:
other: very slight erythema was observed in one out of three animals at 60 minutes. No scoring system was used in the study.
Irritation parameter:
other: slight oedema
Basis:
other: 3 animals
Time point:
other: 60 minutes
Score:
2
Max. score:
3
Reversibility:
no data
Remarks on result:
other: very slight oedema was observed in two out of three animals at 60 minutes. No scoring system was used in the study.
Irritation parameter:
other: necrosis
Basis:
other: 3 animals
Time point:
other: 4 hours
Score:
3
Max. score:
3
Reversibility:
no data
Remarks on result:
other: Necrosis was observed in all three animals at 4 hours. No scoring system was used in the study.
Irritation parameter:
other: slight oedema
Basis:
other: 3 animals
Time point:
other: 4 hours
Score:
2
Max. score:
3
Reversibility:
no data
Remarks on result:
other: very slight oedema was observed in two out of three animals at 4 hours. No scoring system was used in the study.
Irritant / corrosive response data:
Following application for 60 minutes, necrosis was observed in 2 out of the maximum 3 animals. When the test material is applied for 4 hours, necrosis was observed in 3 out of the maximum 3 animals.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Based on the available data, 1,1,3,3-tetramethyl-2-[3-(trimethoxysilyl)propyl]guanidine, is reported to be corrosive to the skin, in a study conducted according to an OECD guideline, but not in compliance with GLP. Applying the criteria of Regulation (EC) No 1272/2008, classification sub-category 1B is applicable because necrosis was observed in 2/3 animals after exposure for 1 hour, and 3/3 animals after exposure for 4 hours.