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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: following the Journal Officiel de la République Française of 21/1/71 and 8/6/73
Principles of method if other than guideline:
The method is similar to OECD guidelines, but the exposure is under occlusive patch and and duration is 24 hours.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-thienylacetyl chloride
EC Number:
254-290-0
EC Name:
2-thienylacetyl chloride
Cas Number:
39098-97-0
Molecular formula:
C6H5ClOS
IUPAC Name:
2-thienylacetyl chloride
Test material form:
liquid
Details on test material:
- Density: 1.29

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: nodata
- Weight at study initiation: between 2.5 and 3.5 kg
- Housing:kept in individual in cages measuring 540x360x315 mm or in restraining devices which allow the back of the animal to be treated.
- Diet: 200 g per animal per day
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 2°C
- Humidity: 55% ± 10%
- Air changes: 12 times per hour
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: treatment on 27 December 1977

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped and abraded/non-abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: right (scarified) and left flanks
- % coverage: 2 cm²
- Type of wrap if used: impregnated gauze maintained with an occlusive patch (Neodermotest roc) consisting of a central circular disc of 22 mm diameter with a surrounding adhesive, perfored plaster 10 mm wide.

REMOVAL OF TEST SUBSTANCE
- Washing: no

OBSERVATION TIME POINTS
24 and 72 hours

SCORING SYSTEM:
- Method of calculation: as in the guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal: all
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal: all
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal: all
Time point:
24 h
Max. score:
4
Remarks on result:
not determinable
Remarks:
the brown color of the product makes the reading impossible
Irritation parameter:
erythema score
Basis:
animal: all
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal: all
Time point:
72 h
Remarks on result:
not determinable
Remarks:
the brown color of the product makes the reading impossible
Irritation parameter:
edema score
Basis:
animal: all
Time point:
48 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Biopsies were done in 3 rabbits at 24 hours and at 48 hours (no-abraded flank).
These biopsies show a massive, totally aphlegmasic coagulation necrosis, reflecting a major caustic process.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
In this study in rabbits, the substance is considered as corrive after a 24-hour exposure.
Executive summary:

In a primary dermal irritation study, NZW rabbits (6 males) were dermally exposed to 0.5 mL of undiluted 2-thienylacetyl chloride for 24 hours under occlusion (on both flanks, one was abraded).  Animals then were observed for 3 days.  Irritation was scored by the method of Draize.

The brown color of the product makes the reading of erythema scores impossible.

The edema score was 4 in all the rabbits at 24 and 72 hours.

Biopsies were at 24 hours and at 48 hours (no-abraded flank), and show a massive, totally aphlegmasic coagulation necrosis, reflecting a major caustic process.

Even if some tests conditions deviate from the current standards (24-hour exposure and occlusive), 2-thienylacetyl chloride is considered as corrosive according to CLP criteria.