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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16/06/1990 to 22/06/1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Resin acids and Rosin acids, esters with trimethylolpropane
EC Number:
284-009-7
EC Name:
Resin acids and Rosin acids, esters with trimethylolpropane
Cas Number:
84776-83-0
Molecular formula:
UVCB substance - Molecular formula Not applicable for UVCBs
IUPAC Name:
Resin acids and Rosin acids, esters with trimethylolpropane
Test material form:
solid
Details on test material:
Vapour pressure: less than 1.4 x 10-3 Pa at 25 °C
Water solubility: 0.06.09x10-4 kg/m-4 g/l
Density: 1.07 x10³ kg/m³ at 19.8 ∓ 0.5 °C
Appearance: pale yellow solid
Melting point: 24.2 to 51.2 ± 0.5 °C (297 to 324 ± 0.5 K)
Boiling point: 418 ± 0.5 °C (691 ± 0.5 K) at 100.9 kPa.
Specific details on test material used for the study:
Test Material: Bevilite 62-85
Appearance: yellow grains
Lot Number: 010121
Source: Bergvik France

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Abbaye de Bellefontaine
- Acclimatation: 5 days
- Mean weight: 2.6 =/-0.1 Kg
- Identification: metallic ear-tags
- Housing: Individual cages
- Room: air conditioned animal room
- Temperature: 20 =/- 3 °C
- Hygrometry: 50 =/- 20% relative humidity
- Light/dark cycle: 12 hours light/ 12 hours dark
- Food: ad libitum
- Water: always available

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A dose of 500 mg of the test substance ground to a fine dust was applied to a 6 cm2 pre-moisted hydrophilic gauze patch saturated with 0.5 ml of water for injectable preparation and this was then applied to the right flank of each animal.
The left flank did not receive any substance and served as a control.
The test substance and the hydrophilic gauze patch were held as a control. The test substance and the hydrophilic gauze patch were held in contact with the skin for 4 hours by means of a adhesive hypoallergic aerated semi occlusive dressing attached to the gauze bandage.
Duration of treatment / exposure:
The single application was performed on the 12.06.90. The animals were kept under observation until the 15.06.90
Observation period:
The animals were kept under observation until the 15.06.90
Number of animals:
6 rabbits
Details on study design:
Please, see "Any other information on material and methods"

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Rabbits exposed to the test material Bevilite 62-85 did not show cutaneous reactions.
Executive summary:

The cutaneous irritation potential of the test material Bevilite 62-85 was determined according the OECD 404 Guideline and under GLP conditions.

Six New Zealand rabbit were used in this study. The day before the treatment, the flanks of each animal were partially clipped with an electrical clipper. Only animals showing no obvious signs of irritation were used for this study.

A dose of 500 mg of the test substance ground to a fine dust was applied to a 6 cm2 pre-moisted hydrophilic gauze patch saturated with 0.5 ml of water for injectable preparation and this was then applied to the right flank of each animal.

The left flank did not receive any substance and served as a control. The test substance and the hydrophilic gauze patch were held as a control. The test substance and the hydrophilic gauze patch were held in contact with the skin for 4 hours by means of an adhesive hypoallergic aerated semi occlusive dressing attached to the gauze bandage. Subsequently, the dressing were removed and the animals were placed back into their individuals cages.

The test substance was not rinsed off after treatment.

Observations for erythema and oedema were done at 1 hr, 24 hr, 48 hr and 72 hr after the treatment. The result of the study showed no cutaneous reactions.