Formaldehyde, reaction products with phenol heptyl derivs. and 1,3,4-thiadiazolidine-2,5-dithione

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 November 1990 to 16 November 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Justification for type of information:

This study was conducted prior to the introduction of in vitro techniques.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Federal Hazardous substances Act (16 CFR 1500)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and phenol, heptyl derivs.

EC Number:

939-460-0

Cas Number:

1471311-26-8

Molecular formula:

Too complex

IUPAC Name:

Reaction product of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and phenol, heptyl derivs.

Test material form:

liquid: viscous

Details on test material:

- Physical state: viscous light brown liquid
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation: Young adult
- Housing: wire mesh suspension cages
- Diet (e.g. ad libitum): Purina Laboratory Rabbit Chow, ad libitum
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 13 November 1990 To: 16 November 1990

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): tested as supplied

Duration of treatment / exposure:

4 hours

Observation period:

24 and 72 hours

Number of animals:

1 male and 1 female

Details on study design:

TEST SITE
- Area of exposure: 1 inch by 1 inch
- Type of wrap if used: gauze patch, adhesive tape, rubber dam and outer layer of gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Patch wiped free with water or mineral oil.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 48

Score:

5.5

Max. score:

6

Reversibility:

no data

Any other information on results incl. tables

Table of Observations

Rabbit Number	Erythema		Oedema
	24 h	72 h	24 h	72 h
100%
1	3LPCS	3LPCS	3	3
2	2SC	2SC	3	3
Mean Total	2.5		3.0

L = Light brown discoloration

P = Erythema taken at perimeter

C = Coriaceousness on site

S = Spreading of erythema beyond site

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material is a skin irritant.

Executive summary:

Test Guidance

Skin irritation study performed by a similar method to Federal Hazardous Substances Act (16 CFR 1500).

Method and Material

Two New Zealand White rabbits were shaved and a 0.5 mL portion of the test material was applied to an intact skin site. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 4 hours and washed .

Treated areas were examined for erythema and oedema using the Draize method of scoring at 24 and 72 hours.

The animals treated were also used simultaneously for the determination of the eye irritation potential of the material; see Key eye irritation Kreuzmann 1990

Results

The neat (100%) test material induced moderate to severe erythema and slight to moderate oedema at 24 and 72 hour observations. Coriaceousness and a light brown discolouration was observed at the application site.

There was no evidence of reversibility over the limited timeframe of the study.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance as Category 2 skin irritant is required for skin corrosion/irritation.