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Diss Factsheets

Administrative data

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:
experimental study
Adequacy of study:
supporting study
Study period:
1987
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Unsuitable test system (not suitable to detect weak sensitisers), challenge dose seems too high
Principles of method if other than guideline:
Mouse ear swelling test
GLP compliance:
not specified
Type of study:
mouse ear swelling test
Species:
mouse
Strain:
CF-1
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breding Laboratories, Kingston, NY
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 20-22 grams
- Housing: in groups of 2 to 5
- Diet: Purina Laboratory Chow # 5001, ad libitum
- Water: municipal water supply, ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 67-76°F
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12


Route:
epicutaneous, open
Vehicle:
other: 70% ethanol
Concentration / amount:
Induction: 1.0% v/v
Challenges: 10% v/v
Route:
epicutaneous, open
Vehicle:
other: 70% ethanol
Concentration / amount:
Induction: 1.0% v/v
Challenges: 10% v/v
No. of animals per dose:
20
Details on study design:
Induction and challenge schedule:

FCA administration: 50% FCA; 20 µL administered to two sides f the abdomen, by intradermal injection

Induction: 1 % active substance open epicutaneous ; 100 µL, on days 1, 2, and 3
Challenge: 10 % active substance open epicutaneous; 10 µL to both the ventral and the dorsal surface of the left ear
Positive control substance(s):
yes
Remarks:
DCNB
Positive control results:
Positive, performed as expected
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10% challenge
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% challenge. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1%. No with. + reactions: 10.0. Total no. in groups: 10.0.


POSITIVE CONTROL: 
80 and 100 % of the animals showed a positive response (at least 20 %  increase in ear thickness) after 24 and 48 h, respectively.

TEST GROUP:
Few animals challenged with the TS showed weakly positive reactions at  challenge or re-challenge in either the test group or 

in the irritation  control group: The incremental increases in ear thickness ranged from 0 -  10 %. 
 

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Octylamine was negative in the MEST. The MEST is, however, not able to identify weak sensitizers. It is therefore concluded that octylamine lacks strong sensitizing properties.
Executive summary:

N-octylamine was negative in a Mouse Ear Swelling Test (MEST) using two groups of 10 treated mice each. The open epicutaneous induction concentration was 1% octylamin, the challenge concentration was 10%. Negative controls and the positive control animals (1% DCNB) performed as expected.

The mouse-ear swelling test (MEST) serves as a screen to detect potent sensitisers (moderate and strong ones). Weak sensitisers are unlikely to be detected in this test. According to EPA guideline OPPTS 870.2600, a negative result in the MEST does not indicate that the substance is a nonsensitizer, and should be confirmed in an accepted test using guinea pigs and or LLNA if appropriate. The test provided no evidence of a sensitising potential of n-octylamine. Also all other amines tested gave no positive response. The functionality of the test system was demonstrated by using an appropriate positive control substance which was clearly positive. Despite the limited number of animals used and the test restrictions, the result can be weighed in relation to the positive control, the dose used to provoke an effect and the negative result obtained with three structure-related primary amines (cyclohexylamine, hexylamine, isopropylamine). Hence, n-octylamine is not considered to be a potent sensitiser and unlikely to elicit a skin allergic reaction (Hoechst, 1987).

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

N-octylamine was negative in a Mouse Ear Swelling Test (MEST) using two groups of 10 treated mice each. The open epicutaneous induction concentration was 1% octylamin, the challenge concentration was 10%. Negative controls and the positive control animals (1% DCNB) performed as expected.

The mouse-ear swelling test (MEST) serves as a screen to detect potent sensitisers (moderate and strong ones). Weak sensitisers are unlikely to be detected in this test. According to EPA guideline OPPTS 870.2600, a negative result in the MEST does not indicate that the substance is a nonsensitizer, and should be confirmed in an accepted test using guinea pigs and or LLNA if appropriate. The test provided no evidence of a sensitising potential of n-octylamine. Also all other amines tested gave no positive response. The functionality of the test system was demonstrated by using an appropriate positive control substance which was clearly positive. Despite the limited number of animals used and the test restrictions, the result can be weighed in relation to the positive control, the dose used to provoke an effect and the negative result obtained with three structure-related primary amines (cyclohexylamine, hexylamine, isopropylamine). Hence, n-octylamine is not considered to be a potent sensitiser and unlikely to elicit a skin allergic reaction (Hoechst, 1987).

Not to be classified as skin sensitiser according to Regulation (EC) No 1272/2008. N-octylamine was negative in a Mouse Ear Swelling Test (MEST) and is therefore unlikely to have strong or moderate sensitising properties. A weak sensitiser test is not required because of the skin corrosion effects (Annex VII, 8.3, column 2).



Migrated from Short description of key information:
N-octylamine was negative in a Mouse Ear Swelling Test (MEST) and is therefore unlikely to have strong or moderate sensitising properties. A weak sensitiser test is not required because of the skin corrosion effects.

Justification for selection of skin sensitisation endpoint:
only experimental study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the criteria set in Regulation (EC) No 1272/2008 a classification for skin sensitisation is not required as available data do not indicate a skin sensitising property.

Additionally, according to REACH Annex VII section 8.3 column 2 skin sensitisation studies (in vitro and in vivo) do not need to be conducted if the substance is classified as skin corrosion. Since this criteria is fulfilled, no additional studies are required.