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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:
11 May 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(occlusive dressing; no information on skin reactions after 3 min of exposure)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,1,3,3-tetramethylguanidine
EC Number:
201-302-7
EC Name:
1,1,3,3-tetramethylguanidine
Cas Number:
80-70-6
Molecular formula:
C5H13N3
IUPAC Name:
N,N,N',N'-tetramethylguanidine
Details on test material:
- Name of test material (as cited in section 1): 1,1,3,3-Tetramethylguanidine

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Morton Commercial Rabbits, Parsonage Farm, Stansted, Essex, UK
- Age at study initiation: at least 11 weeks
- Weight at study initiation: 3.46 kg
- Housing: single in a grid floor cage
- Diet: Standard Rabbit Diet (Special Diets Services Ltd., Stepfield, Witham, Essex, UK), ad libitum
- Water: mains water, ad libitum
- Acclimation period: at least 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13 - 20
- Humidity (%): 40 - 47
- Photoperiod (hrs dark / hrs light): 10 / 14

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:
1 h (the study was terminated after 1 h for humane reasons)
Observation period:
The study was terminated after 1 h of treatment for humane reasons.
Number of animals:
1 female animal (owing to the very high pH of the diluted test article)
Details on study design:
TEST SITE
- Area of exposure: back (6 cm2)
- Type of wrap if used: gauze patch; the patch was occluded and secured using a strip of impermeable adhesive tape (Sleek, Smith & Nephew, Welwyn Garden City, Herts, UK)

REMOVAL OF TEST SUBSTANCE
- Washing: The skin wiped gently with a disposable paper towel moistened with water.
- Time after start of exposure: 1 h

SCORING SYSTEM: Immediately on removal of the patches severe tissue damage was observed. No scoring of the skin irritation could be made. The animal was killed and the study terminated for humane reasons.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
> 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: corrosive
Remarks:
The study was terminated after 1 h and the severe tissue damage precluded any scoring of erythema or edema. The animal was killed for humane reasons and the study terminated. Hence, reversibility of the local effects could not be determined.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
> 4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: corrosive
Remarks:
The study was terminated after 1 h and the severe tissue damage precluded any scoring of erythema or edema. The animal was killed for humane reasons and the study terminated. Hence, reversibility of the local effects could not be determined.
Irritant / corrosive response data:
Vocalisation was noted 2 minutes after application of the test article. The patch was removed after one hour and the severe tissue damage precluded any scoring of erythema or edema. The animal was killed for humane reasons and the study terminated.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: Skin corr. 1B, H314
Executive summary:

The study was performed 1982, following the DOT (Transport Classification) Guidelines. The study was terminated after 1 h and the animal was killed for humane reasons. Therefore, the substance is classified as skin corrosive 1B, H314 according to Regulation (EC) 1272/2008.