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Diss Factsheets

Administrative data

Description of key information

Isopropylamine gave no evidence of a skin-sensitising potential in the guinea-pig maximisation assay

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:
key study
Study period:
Oct./Nov. 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
No LLNA test has been performed as a reliable non-LLNA skin sensitising assay has already been available.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Centre dÉlevage Lebeau, France
- Age at study initiation: no data
- Weight at study initiation: 432 +-34 g (m); 440 +-22 g) (f)
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >=5 d before start


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-1
- Humidity (%): 50 +-20
- Air changes (per hr): no technically forced exchange
- Photoperiod (hrs dark / hrs light): 12 / 12


Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
intradermal induction: 0.1 mL of a 0.1 % dilution in aqueous isotonic saline on day 1 of study
epicutaneous induction: 0.5 mL of 1 % dilution in aqueous isotonic saline on day 8 of study
10 % = maximum non-irritant concentration (epicutaneous challenge)
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
0.5 mL of the Maximum Non Irritant Concentration (10 %) on day 22 of study
No. of animals per dose:
5 m + 5 f (pos. and neg. control groups); 10 m + 10 f (test group)
Details on study design:
RANGE FINDING TESTS:
Minimum Irritant Concentration for id and epicutaneous application


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2x (day 1 and 8)
- Exposure period: 48 h (dermal) following 24h treatment with 0.5 mL 10% laurylsulphate
- Test groups: FCA/saline, FCA + 0.1% TS/saline, 0.1% TS/saline (intradermal); 0.5 mL 1% TS/saline (dermal)
- Control group: FCA/saline, FCA/saline + saline, saline (intradermal); 0.5 mL saline (dermal)
- Site: scapular region
- Frequency of applications: 1x (id), 1x (dermal)
- Duration: 8 d
- Concentrations: 0.1 % (id), 1 % (dermal)


B. CHALLENGE EXPOSURE
- No. of exposures: 1 (dermal)
- Day(s) of challenge: day 22
- Exposure period: 24 h
- Test groups:
- Control group:
- Site: right flank (TS) / left flank (saline)
- Concentrations: 10 %
- Evaluation (hr after challenge): 24 and 48 h

C. OTHER
Clinical observation,
body-weight control until day 25
Necropsy on day 25
Positive control substance(s):
yes
Remarks:
dinitro 2,4-chlorobenzene
Positive control results:
Challenge with 0.1 % DNCB: erythema scores 2 for 4/5 animals, score 1 for 1/5 animals (reading 24 h p.a.)
Challenge with 0.5 % DNCB: erythema scores 4 for 2/5 animals, score 3 for 3/5 animals (reading 24 h p.a.)
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
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: 20.0. Clinical observations: none.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
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: 10.0. Clinical observations: none.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
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: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Group:
positive control
Dose level:
0.5 % dinitro 2.4 chlorobenzene
Total no. in group:
5
Clinical observations:
positive skin sensitization reactions in 100% of the guinea-pigs
Remarks on result:
positive indication of skin sensitisation

Pre-Test

intradermal: 0.1 % were irritant, 1 % necrotic after 24 h post-application

dermal: 10 % not irritant after 24 h post-application, 25 % were necrotic.

Main test

No clinical signs, no mortalities, normal body-weight gain.

After induction, irritation in the control group and necrosis in treated group were observed.

No cutaneous reaction (scores 0) was observed at 24 and 48 h after dermal challenge at the maximum mon-irritant concentration.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test substance was not sensitising
Executive summary:

A guinea pig maximisation test was performed according to OECD guideline 406 with 5 animals per sex in the control group and 10 per sex in the treatment group. Intradermal induction was performed on day 1 of study with 0.1 mL of 0.1 % dilution of the test substance in the vehicle isotonic saline. On day 8, epicutaneous induction was done with 0.5 mL of 1 % test substance dilution. Challenge occured at day 22 of study with 0.5 mL of a 10 % test substance in vehicle for 24 h. Cutaneous reactions were scored 24 and 48 h after the end of this treatment. No clinical signs or deaths were observed, and no cutaneous reactions occured.

The positive control DNCB showed positive results in this test system.

Under the conditions of this study, the test substance was considered to be non-senstising.

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

Isopropylamine was not sensitizing in a guinea pig maximization test in which Dunkin-Hartley guinea pigs (10/sex) were induced by intradermal injection (0.1 %) followed by an epicutaneous patch exposure (1.0 %) and then challenged 2 weeks later with a 10 % solution. None of the test or control animals had a positive reaction after evaluations at 24 and 48 hours post-challenge (Elf Atochem, 1994).


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Neither the results of a sensory irritation study using mice (Gagnaire, 1989) nor the results of a 90 -day rat inhalation study (Monsanto, 1988) indicate a sensitizing potential. Further, no signs of skin sensitisation were seen in guinea pigs (Elf Atochem, 1994).

Moreover, an experimental study is not necessary due to the corrosive character of the submission substance.

Justification for classification or non-classification

Based on the negative findings in in vivo studies it is concluded that isopropylamine has not to be classified as skin sensitising according to Regulation (EC) No 1272/2008. No information on respiratory sensitisation is available.