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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin sensitisation

Based on available read across data (Magnusson and Kligman Guinea-Pig Maximization tests (OECD TG 406)), Isooctane is not considered to be a skin sensitiser.

Respiratory sensitisation

No data available

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was conducted prior to implementation of the LLNA method.
Species:
guinea pig
Strain:
other: p-strain
Sex:
male/female
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
1 % w/v in corn oil for intradermal induction
50 % for topical induction
25 % for topical challenge
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
1 % w/v in corn oil for intradermal induction
50 % for topical induction
25 % for topical challenge
No. of animals per dose:
20 (10 males, 10 females), controls: 10 (5 males, 5 females)
Positive control substance(s):
no
Key result
Group:
negative control
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
0
Group:
test chemical
Dose level:
25 % w/v in corn oil
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no skin sensitization
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 0.0. Group: test group. Dose level: 25 % w/v in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no skin sensitization.
Key result
Reading:
2nd 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
Clinical observations:
no skin sensitization
Remarks on result:
other: Reading: 2nd 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. Clinical observations: no skin sensitization.
Key result
Reading:
other: 3rd 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
Clinical observations:
no skin sensitization
Remarks on result:
other: Reading: other: 3rd 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. Clinical observations: no skin sensitization.
Key result
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
other: not sensitising
Conclusions:
The purpose of this study was to determine the skin sensitization potential of the test substance, hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. Ten male and ten female guinea pigs were used as a test group, and five male and five female guinea pigs were used as a control group. The test group underwent an intradermal induction of 1.0 %w/v test material in corn oil. Then a topical induction of 50% w/v test substance in corn oil. The challenge was done with 25% w/v test material in corn oil. No skin reactions were noted during the challenge. The test substance is not sensitizing.
Executive summary:

The purpose of this study was to determine the skin sensitization potential of the test substance, hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. Ten male and ten female guinea pigs were used as a test group, and five male and five female guinea pigs were used as a control group. The test group underwent an intradermal induction of 1.0 %w/v test material in corn oil. Then a topical induction of 50% w/v test substance in corn oil. The challenge was done with 25% w/v test material in corn oil. No skin reactions were noted during the challenge. The test substance is not sensitizing.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is no skin sensitisation data available for Isooctane. However, data is available for structural analogue, Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics and presented in the dossier. This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

 

Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics

The skin sensitisation potential of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics, was studied in a guinea pig maximization test (Magnusson/Kligman method) similar to OECD 406 (Shell Chemicals, 1977). Guinea pigs (10/sex in treated group and 5/sex in control group) were induced with 1% (w/v) of the test substance in corn oil as a 0.1 ml injection in the shaved shoulder region. Six to eight days later a topical induction of 50% (w/v) test material was applied under an occlusive dressing for 48 hrs. On Day 20-21 guinea pigs were challenged with 25% (w/v) test material applied to the shaved flank. Skin response was evaluated immediately after challenge, and 24 and 48 hours later. The test substance did not cause indication of skin sensitisation in any guinea pig at any evaluation period after challenge.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no reports of respiratory sensitisation from Isooctane in laboratory animals or in humans. However, the read across skin sensitisation study found no indication of skin sensitisation in guinea pigs. With these observations, it is presumed that Isooctane will not be a respiratory sensitising agent.

Justification for classification or non-classification

Based on available read across data, Isooctane does not meet the criteria for classification as a skin or respiratory sensitiser under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).