Tricyclo[3.3.1.13,7]decan-1-aminium, N,N,N-trimethyl-, sulfate (2:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limited documentation, application time not according to OECD TG 404. The test results from the ear are not taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Principles of method if other than guideline:

BASF Test

GLP compliance:

no

Remarks:

pre-GLP study

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium sulphate

EC Number:

231-984-1

EC Name:

Ammonium sulphate

Cas Number:

7783-20-2

Molecular formula:

H3N.1/2H2O4S

IUPAC Name:

diammonium sulfate

Details on test material:

- Name of test material (as cited in study report): ammonium sulfate
- Analytical purity: chemically pure
No further data

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

no data

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): 80%

Duration of treatment / exposure:

up to 20 hours (back)

Observation period:

8 days

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: back

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: at the end of the respective application period

SCORING SYSTEM:
BASF scoring system, convertible to Draize score system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: 20 h exposure

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Remarks on result:

other: 20 h exposure

Irritant / corrosive response data:

Barely visible skin erythema (equivalent to a Draize score of 0) was noted at 24 hours after exposure when test substance was applied for 5 minutes, 15 minutes or 20 hours. No effects were noted at 8 days after the end of the exposure or after exposure to the test substance for only 1 minute. Neither scaling nor edema were noted at any observation time.

Other effects:

No mortality occurred and there were no clinical signs of toxicity observed.

Any other information on results incl. tables

Table: Draize scores

Application site	Application time	Findings at
		24 hours		8 days
		Erythema	edema
Back	1 min	no findings		no findings
	5  min	1	0	no findings
	15 min	1	0	no findings
	20 h	1	0	no findings

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Executive summary:

An 80% aqueous suspension of the test substance was not irritating when applied to the dorsal skin of rabbits for up to 20 hours under occlusive conditions.