Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Isoheptane was not a dermal sensitizer using a read across Magnusson and Kligman Guinea-Pig Maximization test (OECD TG 406).

 

Respiratory Sensitisation

no data

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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
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.
Reading:
1st reading
Group:
negative control
Remarks on result:
other: Not specified
Reading:
1st reading
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 conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is no data available for Isoheptane. However, data is available for a structural analogue, Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics and Hydrocarbons, C7-C9, isoalkanes and presented in the dossier. This data is read across to Isoheptane 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 sensitization potential of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics, was studied in a guinea pig maximization test (Magnusson/Kligman method) similar to OECD 406. 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 sensitization in any guinea pig at any evaluation period after challenge (Shell Chemicals, 1977).

Human Data

Hydrocarbons, C7-C9, isoalkanes

There are human data available for skin sensitisation on hydrocarbons, C7-C9, iso-alkanes. The human data show that there was no evidence that the test material possesses a skin sensitising potential (Exxon Mobil, 1962d, Exxon Mobil, 1988a) or is a photosensitiser (Exxon Mobil, 1988b).


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no reports of respiratory sensitization from Isoheptane in laboratory animals or humans. However, skin sensitization studies utilizing Hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics, found no indication of skin sensitization in guinea pigs. With these observations, it is presumed that Isoheptane will not be a respiratory sensitizing agent.

Justification for classification or non-classification

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