Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Incomplete report; Inadequate details of study design and results; Composition uncertain.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1958

Report date:

1958

Materials and methods

Test guideline

Qualifier:

no guideline available

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Quaternary ammonium compounds, coco alkylbis(hydroxyethyl)methyl, chlorides

EC Number:

274-846-6

EC Name:

Quaternary ammonium compounds, coco alkylbis(hydroxyethyl)methyl, chlorides

Cas Number:

70750-47-9

IUPAC Name:

70750-47-9

Constituent 2

Reference substance name:

In the report, the substance is presented under CAS no 70750-47-9. This CAS no does not describe the substance correctly, instead CAS no 71808-83-2 should be used.

IUPAC Name:

In the report, the substance is presented under CAS no 70750-47-9. This CAS no does not describe the substance correctly, instead CAS no 71808-83-2 should be used.

Constituent 3

Reference substance name:

The product tested consists of C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2)

IUPAC Name:

The product tested consists of C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2)

Details on test material:

67.2% active (SDS 67%)

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye served as a control

Amount / concentration applied:

0.1 ml

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

one

Details on study design:

Exactly 0.1 ml of the undiluted test material was instilled into the conjunctival sac of the right eye of a single albino rabbit. The left eye served as a
scoring control. One. 24. 48. 72, 96 hours, and 7 days after the instillation. the cornea. iris. and palpebral conjunctiva were graded individually for
eye irritation and injury according to a standard scoring system. Zero score indicates no irritation whatever while the maximum score (110) indicates maximal irritation and injury to all three ocultar tissues.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

animal #1

Max. score:

110

Reversibility:

not reversible

Irritant / corrosive response data:

The results indicated undiluted Test Material to be maximally irritating to occular tissues. Although not included in the scores there
was little or no improvement noted in the condition of the treated eye after 14 days.

Any other information on results incl. tables

Eye irritation scores
Time	1 hours	24 hours	48 hours	72 hours	96 hours	7 days	Maximum Possible Score
Cornea	60	60	80	60	80	80	80
Iris	10	10	10	10	10	10	10
Conjunctiva	14	15	20	20	20	20	20
Total	84	86	110	110	110	110	110

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information

Conclusions:

The results indicated undiluted Test Material to be maximally irritating to ocular tissues. Although not included in the scores. there was little or no improvement noted in the condition of the treated eye after 14 days.

Executive summary:

The product tested was evaluated for its effects when instilled into rabbit eyes. The results indicates severely irritation to rabbit eyes. The maximum irritation score was 110 out of a possible 110.

Label Requirements under GHS: Symbol "Corrosion"; Signal word "Danger"; Hazard statement H318: "Causes serious eye damage"