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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given:comparable to guidelines/standards.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
other: P
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shell Toxicology Laboratory, Breeding Unit
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Intradermal induction: 0.1 % w/v in corn oil
Topical induction: 50.0 % w/v in corn oil
Topical challenge: 25.0 % w/v in corn oil
Route:
other: epicutaneous
Vehicle:
corn oil
Concentration / amount:
Intradermal induction: 0.1 % w/v in corn oil
Topical induction: 50.0 % w/v in corn oil
Topical challenge: 25.0 % w/v in corn oil
No. of animals per dose:
10 males and 10 females were used in the exposure group
5 males and 5 females were used in the control group
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25% w/v in corn oil
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: 25% w/v in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25% w/v in corn oil
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: 25% w/v in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.

Skin Response After Challenge Procedure

Animal – Exposure Group

Immediate

24 hrs

48 hrs

Male 1

-

-

-

Male 2

-

-

-

Male 3

-

-

-

Male 4

-

-

-

Male 5

-

-

-

Male 6

-

-

-

Male 7

-

-

-

Male 8

-

-

-

Male 9

-

-

-

Male 10

-

-

-

Female 1

-

-

-

Female 2

-

-

-

Female 3

-

-

-

Female 4

-

-

-

Female 5

-

-

-

Female 6

-

-

-

Female 7

-

-

-

Female 8

-

-

-

Female 9

-

-

-

Female 10

-

-

-

Control Group

Male 1

-

-

-

Male 2

-

-

-

Male 3

-

-

-

Male 4

-

-

-

Male 5

-

-

-

Female 1

-

-

-

Female 2

-

-

-

Female 3

-

-

-

Female 4

-

-

-

Female 5

-

-

-

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test substance did not cause any skin response during the challenge procedure. The test substance is considered not sensitizing.
Executive summary:

This study examined the skin sensitization potential of Dilutene M5. Groups of 10 male and 10 female guinea pigs were induced with 0.1 % w/v of test substance in corn oil intradermally. 5 male and 5 female guinea pigs served as controls. The topical induction was performed with 50% w/v of test substance in corn oil. A topical challenge was then done with 25% w/v of test substance in corn oil. Animals were then scored for dermal reactions. No reaction was seen in any animal at any time during the experiment. The test substance is not sensitizing to skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitisation assessment of Alchisor TAL 111 is based on read-across data from C9-C14 aliphatics (2-25% aromatics). An animal study on C9-C14 aliphatics (2-25% aromatics) gave a negative response. This result is supported by the negative result obtained from a Human Repeated Insult Patch Test (HRIPT) using 101 human volunteers.


Migrated from Short description of key information:
The available study gave a negative response in the available animal study. A negative response was also obtained in a human volunteer study.

Justification for selection of skin sensitisation endpoint:
Only one animal study available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no reports of respiratory sensitization from C9-14 aliphatics (2-25% aromatics) in laboratory animals or humans.  A skin sensitisation study utilizing C9-14 aliphatics (2-25% aromatics) found no indication of skin sensitisation in guinea pigs.  Additional studies in humans also found no indication of skin sensitisation.  Based on these findings, it is unlikely that C9-14 aliphatics (2-25% aromatics) will be a respiratory sensitiser.

Justification for classification or non-classification

Based on the available read-across data, the substance does not meet the criteria for classification.