1,1,3,3-tetramethylguanidine

Skin irritation / corrosion

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

Test material information

Constituent 1

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

Results

Results 1

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.

Results 2

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.