Propylidynetrimethanol, propoxylated, reaction products with ammonia

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

Due to animal welfare reasons, the potential of severe irritation is determined in the HET-CAM in vitro system before deciding on a possible study in the rabbit as suggested in OECD Guideline 405.

Deviations:

no

Remarks:

The HET-CAM Test is an alternative in vitro method for testing of severe eye/mucous membrane damage using the chorionallantoic membrane of fertilized, incubated hen eggs.

Principles of method if other than guideline:

The study was performed according to the methods described in the following publications:
- Lüpke N.P. (1985): Hen's Egg Chorioallantoic Membrane Test for Irritation Potential. Fd. Chem. Toxic. 23, pp. 287 -291.
- Spielmann, H. (1995): HET-CAM Test. In: Methods in Molecular Biology, 43 (eds.:O'Hare, S. and Atterwill, 0. K.) pp. 199 -204
- Spielmann, H. et al. (1996): Results of a Validation Study in Germany on Two In Vitro Alternatives to the Draize Eye Irritation Test the HET-CAM Test and the 3T3 NRU Cytotoxicity Test. ATLA 24, pp. 741 -858.
In addition the study follows the testing strategy tor determination of eye irritation/corrosion as given in the following guideline:
Organization for Economic Co-operation and Development (OECD), OECD Guidelinestor testing of chemicals, Guideline No. 405:
Acute Eye Irritation/Corrosion", adopted April 24, 2002.

GLP compliance:

no

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

Name of test material: Trimethylolpropanepoly(oxypropylene)triamine
EC no.: 500-105-6
CAS no.: 39423-51-3
Physical state: clear colourless liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: ABl. Nr. 85-4113
- Date of production: November 16, 2000

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: was guaranteed by the sponsor

OTHER SPECIFICS:
- Name of test material (as cited in study report): Polyetheramin T 403; Substance No.: 01/0618-1
- Analytical purity: 93.9 %
- Homogeneity: Homogeneous by visual inspection

Test animals / tissue source

Species:

other: HET-CAM in vitro corrosion test

Strain:

other: hen eggs

Test system

Vehicle:

water

Controls:

no

Amount / concentration applied:

10, 100 %

Duration of treatment / exposure:

up to a maximum time period of 3.5 minutes

Observation period (in vivo):

210 seconds

Number of animals or in vitro replicates:

3 eggs for 10 and 100 %

Details on study design:

Type of eggs: Fresh, fertilized hen eggs produced under controlled SPF conditions.
Strain/quality: White Leghorn, SPAFAS Inc., USA, SPF Premium.
Origin: Charles River Deutschland GmbH, Extertal.
Identification: At start of incubation period continuous numbering of the eggs with a felt pen.
Reasons for the selection: Hen eggs are recommended as preferred type of eggs in the quoted references. Analogous to test animals, controlled SPF housing guarantees a defined microbiological status of the eggs.
Climate: Breeding in an incubator at constant temperature of 37.5°C (± 0.5°C) and a relative humidity of 62.5% (± 7.5%).
Automatic rotating device: Until including incubation day 8 and/or day 9, the eggs were rotated automatically 5 times a day. On the day before application the eggs were placed with the blunt end upward and were not rotated until preparation. The incubation conditions were checked daily. Deviations were recorded.
Candling of the eggs: The eggs were candled before the start of incubation and on the 9th and/or 10th day. Any defective or unfertilized eggs were discarded.

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

in vitro irritation score

Run / experiment:

egg no. 1

Value:

19.2

Results 2

Irritation parameter:

in vitro irritation score

Run / experiment:

egg no. 2

Value:

19.1

Results 3

Irritation parameter:

in vitro irritation score

Run / experiment:

egg no. 3

Value:

18.9

Results 4

Irritation parameter:

in vitro irritation score

Run / experiment:

egg no. 1

Value:

19.9

Results 5

Irritation parameter:

in vitro irritation score

Run / experiment:

egg no. 2

Value:

19.6

Results 6

Irritation parameter:

in vitro irritation score

Run / experiment:

egg no. 3

Value:

19.4

Any other information on results incl. tables

Concentration	Egg No.	Time (seconds) until appearance of:			Index for Irritation
		Haemorrhagia:	Lysis:	Coagulation:
Undiluted test substance	1	5.0	38.0	30.0	19.2
	2	6.0	39.0	33.0	19.1
	3	9.0	41.0	37.0	18.9
Mean	n= 3	6.7	39.3	33.3	19.0
Concentration	Egg No.	Time (seconds) until appearance of:			Index for Irritation
		Haemorrhagia:	Lysis:	Coagulation:
Test substance 10% in doubly distilled water	1	8.0	22.0	17.0	19.9
	2	13.0	25.0	21.0	19.6
	3	19.0	29.0	23.0	19.4
Mean	n= 3	13.3	25.3	20.3	19.6

Evaluation: May cause severe eye damage.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Classification: category 1 (serious eye damage)