Urea, reaction products with diethylene glycol, formaldehyde and glyoxal

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fixapret PC, vor Magnesiumchlorid-Zugabe

IUPAC Name:

Fixapret PC, vor Magnesiumchlorid-Zugabe

Details on test material:

- Name of test material (as cited in study report): Fixapret PC, vor Magnesiumchlorid-Zugabe
- Physical state: liquid
- Analytical purity: Reaction product of urea, formaldehyde, glyoxal and diethylene glycol, content: 62.1 % in water
- Impurities (identity and concentrations): 37.9 % water (solvent)
- Lot/batch No.: 153
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor,
and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature; avoid temperatures < 5°C >30°C

Test animals

Species:

other: reconstructed human epidermis

Strain:

not specified

Details on test animals or test system and environmental conditions:

not applicable: in vitro study

Test system

Amount / concentration applied:

single topical application of 30 μL of the test substance

Duration of treatment / exposure:

1 hour treatment

Observation period:

42-hours post-incubation period

Number of animals:

9 EpiDerm™ Tissues (3 test substance, 3 negative control, 3 positive control)

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: mean OD570, test substance

Value:

1.939

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 42 hours. Remarks: viability of treated tissues = OD570 (test substance)/OD570(negative control). (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: mean OD570, negative control

Value:

1.981

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 42 hours. (migrated information)

Results 3

Irritation / corrosion parameter:

other: other: viability (% of negative control)

Value:

98

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 42 hours. Max. score: 100.0. Remarks: viability <50% = irritant; >50% = non-irritant; the positive control included in the test design had the expected value . (migrated information)

Any other information on results incl. tables

The EpiDerm skin irritation test showed the following results: The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 98%. The viability was calculated by the ratio of the OD570 of the test substance and the OD570 of the negative control.

Mean tissue viability (% of negative control)	Prediction
≤ 50	irritant
> 50	non-irritant

Test substance		mean	Standard Deviation
NC	mean OD570	1.981
	viability [% of NC]	100	2.97
11/0428-1	mean OD570	1.939
	viability [% of NC]	98	3.96
PC	mean OD570	0.108
	viability [% of NC]	5	0.42

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

Based on the observed results it was concluded, that Fixapret PC, vor Magnesiumchlorid-Zugabe does not show a skin
irritation potential in the EpiDermTM skin irritation test under the test conditions chosen.