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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted according to guideline method
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted according to guideline method
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Principles of method if other than guideline:
n/a
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Acceptable guinea pig maximisation test that followed sound scientific principles.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Route:
other: intradermal and epicutaneous
Vehicle:
other: Alembicol D
Concentration / amount:
Induction: 7.5% w/w for intradermal ; 83.3% w/w for epicutaneous
Challenge: 83.3% and 41.65% w/w
Route:
epicutaneous, occlusive
Vehicle:
other: Alembicol D
Concentration / amount:
Induction: 7.5% w/w for intradermal ; 83.3% w/w for epicutaneous
Challenge: 83.3% and 41.65% w/w
No. of animals per dose:
20 test
20 control
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
41.65%w/w
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 41.65%w/w. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
41.65%w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 41.65%w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
41.65%w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 41.65%w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
83.3%w/v
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
All reactions were slight oedema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 83.3%w/v. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: All reactions were slight oedema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
83.3% w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 83.3% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
83.3% w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 83.3% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
41.65% w/w
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 41.65% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
41.65% w/w
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 41.65% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
41.65% w/w
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 41.65% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
83.3% w/w
No. with + reactions:
9
Total no. in group:
20
Clinical observations:
All reactions were slight oedema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 83.3% w/w. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: All reactions were slight oedema.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
83.3% w/w
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 83.3% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
83.3% w/w
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 83.3% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: Not specified
Group:
positive control
Remarks on result:
other: positive control not specified

No signs of ill health or toxicity were recorded. The bodyweight increases in test animals were comparable to controls.

Following intradermal injections, necrosis was recorded at sites receiving Freund's Complete Adjuvant in test and control animals. Irritation was seen in the animals at sites receiving the test material 7.5% w/w in Alembicol D by intradermal injection and very slight irritation was observed in control animals receiving Alembicol D.

Moderate erythema was observed in test animals following topical application with test material at 83.3% w/w in Alembicol D. Slight erythema was seen in the control guinea-pigs.

Interpretation of results:
other: Not sensitising
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under conditions of this study, Resin acids and Rosin acids, fumarated, esters with pentaerythritol is not considered to be a sensitizer in female guinea pigs when tested in the Guinea Pig Maximization Test (GPMT).

Based on the outcome of this study, this material is not classifiable for skin sensitization according to UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. Resin acids and Rosin acids, fumarated, esters with pentaerythritol is not classified in the Annex I of Directive 67/548/EEC.
Executive summary:

This is a Guinea Pig Maximisation Test conducted according to OECD 406 guideline (Huntingdon Research Centre Ltd, 1992). Twenty female guinea pigs were induced with rosin, fumarated, ester with pentaerythritol (7.5% w/w in Alembicol D by intradermal injection, 83.3% w/w in Alembicol D by epicutaneous administration). Along with the test animals, a group of 20 control animals, previously not induced were challenged dermally with 41.65% or 83.3% w/w. Treated animals induced similar dermal response to controls when challenged at 83.3% and 41.65% w/w in Alembicol D through epicutaneous route. Therefore, under the conditions of this study the test material is not a sensitiser.

The result is not inconsistent with the weak positive result in the mouse LLNA. However, as the mouse LLNA is the preferred test, the result of this test is over-ruled by the result of the mouse LLNA and the mouse LLNA is therefore designated the key study and used for classification.

Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Principles of method if other than guideline:
n/a
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Acceptable guinea pig maximisation test that followed sound scientific principles.

Test material

Constituent 1
Reference substance name:
Resin acids and Rosin acids, fumarated, esters with pentaerythritol
EC Number:
305-514-1
EC Name:
Resin acids and Rosin acids, fumarated, esters with pentaerythritol
Cas Number:
94581-15-4
IUPAC Name:
94581-15-4
Details on test material:
- Name of test material (as cited in study report): Bevilite 62-115L
- Substance type: Reaction product derived from UVCB
- Physical state: Yellow pastillated solid material.
- Analytical purity: 100%
- Lot/batch No.: 110212
- Expiration date of the lot/batch: 21 May 1992
- Storage condition of test material: -20C in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intradermal and epicutaneous
Vehicle:
other: Alembicol D
Concentration / amount:
Induction: 7.5% w/w for intradermal ; 83.3% w/w for epicutaneous
Challenge: 83.3% and 41.65% w/w
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Alembicol D
Concentration / amount:
Induction: 7.5% w/w for intradermal ; 83.3% w/w for epicutaneous
Challenge: 83.3% and 41.65% w/w
No. of animals per dose:
20 test
20 control

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
41.65%w/w
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 41.65%w/w. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
41.65%w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 41.65%w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
41.65%w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 41.65%w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
83.3%w/v
No. with + reactions:
6
Total no. in group:
20
Clinical observations:
All reactions were slight oedema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 83.3%w/v. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: All reactions were slight oedema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
83.3% w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 83.3% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
83.3% w/v
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 83.3% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
41.65% w/w
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 41.65% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
41.65% w/w
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 41.65% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
41.65% w/w
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 41.65% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
83.3% w/w
No. with + reactions:
9
Total no. in group:
20
Clinical observations:
All reactions were slight oedema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 83.3% w/w. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: All reactions were slight oedema.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
83.3% w/w
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 83.3% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
83.3% w/w
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 83.3% w/w. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: Not specified
Group:
positive control
Remarks on result:
other: Positive control not specified

Any other information on results incl. tables

No signs of ill health or toxicity were recorded. The bodyweight increases in test animals were comparable to controls.

Following intradermal injections, necrosis was recorded at sites receiving Freund's Complete Adjuvant in test and control animals. Irritation was seen in the animals at sites receiving the test material 7.5% w/w in Alembicol D by intradermal injection and very slight irritation was observed in control animals receiving Alembicol D.

Moderate erythema was observed in test animals following topical application with test material at 83.3% w/w in Alembicol D. Slight erythema was seen in the control guinea-pigs.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitising
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under conditions of this study, Resin acids and Rosin acids, fumarated, esters with pentaerythritol is not considered to be a sensitizer in female guinea pigs when tested in the Guinea Pig Maximization Test (GPMT).

Based on the outcome of this study, this material is not classifiable for skin sensitization according to UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. Resin acids and Rosin acids, fumarated, esters with pentaerythritol is not classified in the Annex I of Directive 67/548/EEC.
Executive summary:

This is a Guinea Pig Maximisation Test conducted according to OECD 406 guideline (Huntingdon Research Centre Ltd, 1992). Twenty female guinea pigs were induced with rosin, fumarated, ester with pentaerythritol (7.5% w/w in Alembicol D by intradermal injection, 83.3% w/w in Alembicol D by epicutaneous administration). Along with the test animals, a group of 20 control animals, previously not induced were challenged dermally with 41.65% or 83.3% w/w. Treated animals induced similar dermal response to controls when challenged at 83.3% and 41.65% w/w in Alembicol D through epicutaneous route. Therefore, under the conditions of this study the test material is not a sensitiser.

The result is not inconsistent with the weak positive result in the mouse LLNA. However, as the mouse LLNA is the preferred test, the result of this test is over-ruled by the result of the mouse LLNA and the mouse LLNA is therefore designated the key study and used for classification.