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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
18 Jan - 11 Feb 1984
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
positive control missing, substance purity not given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted in 1992
Deviations:
yes
Remarks:
no reliablity check was performed
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted prior to the current requirement in Regulation (EC) 1907/2006 to perform an LLNA study (OECD 429) as the preferred in vivo skin sensitisation study.

Test material

Constituent 1
Chemical structure
Reference substance name:
(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide
EC Number:
261-684-6
EC Name:
(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide
Cas Number:
59272-84-3
Molecular formula:
C21H42N2O3
IUPAC Name:
(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide
Test material form:
solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Remarks:
albino
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, The Netherlands
- Weight at study initiation: males: 237 - 315 g; females: 235 - 295 g
- Housing: individual in suspended stainless steel cages, fitted with wire mesh floors and fronts
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days
- Indication of any skin lesions: no

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 1
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
20%
Day(s)/duration:
1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
10%
Day(s)/duration:
48 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
Route:
epicutaneous, semiocclusive
Vehicle:
other: vaseline
Concentration / amount:
5% or 1%
Day(s)/duration:
24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 animals (10 male and 10 female) for test group and 10 animals (5 male and 5 female) for control group
Details on study design:
RANGE FINDING TESTS: no data available

MAIN STUDY
A. INDUCTION EXPOSURE
Induction is effected in a two-stage operation consisting of, firstly, three pairs of intradermal injections made simultaneously and, secondly, one week later, a closed patch exposure performed over the injection sites. For this purpose an area of c. 24 cm² of dorsal skin in the shoulder region is clipped free of hair with electric clippers.

Intradermal injections:
Three pairs of intradermal injections are made in the clipped area.
The preparations injected into the skin of the test animals are the following:
- sites a(left) and a(right): Freund’s Complete Adjuvant (FCA)
- sites b(left) and b(right): a dilution of the test substance in a suitable carrier (propylene glycol)
- sites c(left) and c(right): a dilution of the test substance in a mixture of FCA and carrier (1:1).
The preparations injected into the skin of the control animals are the following:
- sites a(left) and a(right): FCA
- sites b(left) and b(right): carrier
- sites c(left) and c(right): a mixture of FCA and carrier (1:1).

Skin readings are made 24 h after the treatment.

Topical application:
One week after induction by the intradermal injections the same area of the skin of the animals is closely shaved again. The test animals are treated as follows:
A 2 x 4 cm patch of Whatman No 3 MM filter paper is loaded with the appropriate mixture of the test substance and carrier. The patch is placed over the sites of the intradermal injections and covered with a piece of PVC foil and a piece of Leukopor hypo-allergic paper bandage. This, in turn, is secured with a 7.5 cm wide Tensoplast bandage. The dressing is left in place for 48 h. The control animals are similarly treated with patches with carrier (vaseline) only.
Skin readings are made after removal of the patches.


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after topical induction
- Exposure period: 24 hours
- Test groups: test substance
- Control group: test substance
- Site: left flank
- Concentrations: 5 or 1%
- Evaluation (hr after challenge): 24 and 48 hours
Positive control substance(s):
not specified

Results and discussion

Positive control results:
no data available

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5% at challenge
No. with + reactions:
1
Total no. in group:
9
Clinical observations:
1 male with score 1 for erythema and edema, respectively
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5% at challenge
No. with + reactions:
0
Total no. in group:
9
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20% intradermal induction, 10% topical induction, 5% at challenge
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
1 male with edema score of 1 and one male with erythema and edema score 1
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20% intradermal induction, 10% topical induction, 5% at challenge
No. with + reactions:
0
Total no. in group:
20
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

One control female died on Day 9 of the study because of a prolapse of the rectum. All other animals remained in good health during the experimental period.

The challenge treatment with a 1% dilution - a concentration which is one fifth of the non-irritant concentration - did not elicit any sensitisation reaction under the conditions of the test.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification