Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

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Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
15 October - 17 December 1975
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Non-GLP study, meets generally accepted scientific principles, but test conditions and results not sufficiently detailed.
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Colworth guinea pig intradermal injection test: Guinea pigs were treated to induce sensitization by intradermal injections and were challenged approximately 2 weeks later by intradermal injection and topical application. As there was no evidence of sensitization at first challenge the induction and challenge sequences were repeated. Confirmatory further challenges were also done.
GLP compliance:
no
Remarks:
pre-GLP
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
no details
Route:
intradermal
Vehicle:
other: intradermal injection - Dobs/saline; topical application - absolute alcohol
Concentration / amount:
Induction phase (intradermal injection): 1.875 %
Challenge phase:
- Intradermal injection: 0.75 % (up to 4th challenge)
- Topical application: 60 % (up to 4th challenge)
- Further challenges: 40 and 60 % topical application
Route:
intradermal and epicutaneous
Vehicle:
other: intradermal injection - Dobs/saline; topical application - absolute alcohol
Concentration / amount:
Induction phase (intradermal injection): 1.875 %
Challenge phase:
- Intradermal injection: 0.75 % (up to 4th challenge)
- Topical application: 60 % (up to 4th challenge)
- Further challenges: 40 and 60 % topical application
No. of animals per dose:
Main test: 4 males for control and 10 animals (2 males and 8 females) for test item
Reading:
other: challenge 1, 3 and 4
Group:
test group
Dose level:
0.75 % intradermal injection
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 1, 3 and 4. Group: test group. Dose level: 0.75 % intradermal injection. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: challenge 1 after the first induction injection
Group:
test group
Dose level:
60 % topical application
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 1 after the first induction injection. Group: test group. Dose level: 60 % topical application. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: challenge 3 after the second induction injection
Group:
test group
Dose level:
60 % topical application
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 3 after the second induction injection. Group: test group. Dose level: 60 % topical application. No with. + reactions: 1.0. Total no. in groups: 10.0.
Reading:
other: challenge 3
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: challenge 3. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: challenge 4 after the second induction injection
Group:
test group
Dose level:
60 % topical application
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 4 after the second induction injection. Group: test group. Dose level: 60 % topical application. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: challenge 4
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: challenge 4. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: challenge 5 after the second induction injection
Group:
test group
Dose level:
40 % topical application
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 5 after the second induction injection. Group: test group. Dose level: 40 % topical application. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: challenge 5 after the second induction injection
Group:
test group
Dose level:
60 % topical application
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 5 after the second induction injection. Group: test group. Dose level: 60 % topical application. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: challenge 5
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: challenge 5. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: challenge 6 after the second induction injection
Group:
test group
Dose level:
40 % topical application
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 6 after the second induction injection. Group: test group. Dose level: 40 % topical application. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: challenge 6 after the second induction injection
Group:
test group
Dose level:
60 % topical application
No. with + reactions:
3
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 6 after the second induction injection. Group: test group. Dose level: 60 % topical application. No with. + reactions: 3.0. Total no. in groups: 10.0.
Reading:
other: challenge 6
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: challenge 6. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
other: challenge 7 after the second induction injection
Group:
test group
Dose level:
40 % topical application
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 7 after the second induction injection. Group: test group. Dose level: 40 % topical application. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: challenge 7 after the second induction injection
Group:
test group
Dose level:
60 % topical application
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: other: challenge 7 after the second induction injection. Group: test group. Dose level: 60 % topical application. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
other: challenge 7
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: other: challenge 7. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0.

None

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, Pine Needle Siberica induced weak sensitisation in guinea pigs.
Executive summary:

In a skin sensitisation test, ten guinea pigs (males and females) were treated with test item, Pine Needle Siberica by intradermal injections (1.875 %) and were challenged approximately 2 weeks later by intradermal injection (0.75 %) and topical application (60 %). As there was no evidence of sensitization at first challenge the induction and challenge sequences were repeated. Confirmatory further challenges were also done (40 and 60 % topical application). The test concentrations for the main study were determined from a preliminary study at the concentrations ranging from 0.05 % to 1 % (intradermal injection) and 15 to 100 % (topical application).    

 

During challenge phase, 1/10 positive reactions at the 3rd challenge, 3/10 positive reactions at the 6th challenge, 2/10 positive reactions at the 7th challenge were observed. No reactions were observed in control group.

 

Under the test conditions, Pine Needle Siberica induced weak sensitisation in guinea pigs.

Endpoint:
skin sensitisation, other
Remarks:
Classification based on calculation rules for mixtures of the CLP Regulation
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
accepted calculation method
Qualifier:
no guideline required
Principles of method if other than guideline:
Classification based on calculation rules for mixtures of the CLP Regulation
Key result
Parameter:
other: Classification
Remarks on result:
other: Skin sensitiser category 1B
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Executive summary:

The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation. The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2015) was used to determine the skin sensitising potential of the registered substance.

The registered substance has not been tested itself in appropriate in vitro or in vivo tests but some of its constituents are classified as skin sensitisers Cat.1B (pinene alpha, pinene beta, limonene, delta 3 carene and terpinolene)

and are all potentially present above the CLP generic concentration limit of 1% that triggers classification of the mixture. Therefore, the registered substance is classified as a skin sensitiser Cat. 1B without further testing according to the Regulation (EC) No 1272/2008.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2015) was used to determine the skin sensitising potential of Pine needle oil.

Some ingredients of Pine needle oil have been classified as skin sensitizers Cat.1 (pinene alpha and beta, limonene, delta 3 carene, Terpinolene) and are all present above the generic concentration limit of 1%. Therefore Pine needle oil shall be classified as a skin sensitizer without further testing according to the Regulation (EC) No 1272/2008 .

This conclusion is supported by a guinea pig maximisation test (Storch, 1975) in which positive reactions were observed after a minimum of 3 challenges. 3/10 animals were positive for skin sensitisation at the 6th challenge.

Source: ECHA disseminated dossiers

- Pinene alpha:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d952924-c8ed-4614-e044-00144f67d249/DISS-9d952924-c8ed-4614-e044-00144f67d249_DISS-9d952924-c8ed-4614-e044-00144f67d249.html

- Pinene beta:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d85bc06-0d47-6e67-e044-00144f67d249/DISS-9d85bc06-0d47-6e67-e044-00144f67d249_DISS-9d85bc06-0d47-6e67-e044-00144f67d249.html

- Limonene:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb16d5d-b83e-2831-e044-00144f67d031/DISS-9eb16d5d-b83e-2831-e044-00144f67d031_DISS-9eb16d5d-b83e-2831-e044-00144f67d031.html

- Delta-3 -carene:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9ead810f-31dc-543d-e044-00144f67d031/DISS-9ead810f-31dc-543d-e044-00144f67d031_DISS-9ead810f-31dc-543d-e044-00144f67d031.html

- Terpinolene:

http://apps.echa.europa.eu/registered/data/dossiers/DISS-e1a0ab01-dbd6-2fde-e044-00144f67d031/DISS-e1a0ab01-dbd6-2fde-e044-00144f67d031_DISS-e1a0ab01-dbd6-2fde-e044-00144f67d031.html


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Harmonized classification:

Pine needle oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Based on the typical composition provided by the Lead Registrant, Pine needle oil is classified as skin sensitizer:

- May cause sensitisation by skin contact (Xi; R43) according to the Directive 1999/45/EEC,

- Skin Sens. 1B, H317 (May cause an allergic skin reaction) according to the Regulation (EC) No. 1272/2008 (CLP).

No information was available regarding respiratory sensitisation.