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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:
key study
Study period:
05/2002-03/2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Existing study conducted before the LLNA requirement

Test material

Constituent 1
Reference substance name:
Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)
EC Number:
701-204-9
Cas Number:
68784-17-8
IUPAC Name:
Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)
Test material form:
liquid: viscous
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: TS01007
Alkanoic acid amide
CAS#68784-17-8

- Expiration date of the lot/batch: 01/01/2003
- Description: Yellow to light amber viscous liquid
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at room temperature
- Stability under test conditions: Stable
- Solubility and stability of the test substance in the solvent/vehicle: Soluble in USP grade mineral oil (vehicle)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab Animals, Inc., Scottdale, PA
- Females nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: Only healthy animals chosen for study
- Age at study initiation: Approximately 7 and 9 weeks for males and females, respectively
- Weight at study initiation: Males (348-461); Females (336-429)
- Housing: individually in suspended stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 49-77%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: May 28, 2002 To: July 4, 2002

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
75%
Day(s)/duration:
Once a week for 3 consecutive weeks; chambers removed after 6 hrs
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
25%
Day(s)/duration:
1day/ 6 hr duration
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
25%
Day(s)/duration:
1 day/ 6 hr duration
Adequacy of challenge:
highest non-irritant concentration
No.:
#3
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
10%
Day(s)/duration:
1 day/ 6 hr duration
Adequacy of challenge:
not specified
No. of animals per dose:
10 males and 10 females
Details on study design:
Following challenge with 25% w/w Alkanoic acid amide in USP mineral oil, dermal scores of 1 were noted in 4/20 test animals following the 24- and 48-hour scoring intervals. Dermal reactions in the remaining test, vehicle challenge control and naive challenge control animals were limited to scores of 0 to +/-.
Following rechallenge with 25% w/w Alkanoic acid amide in USP mineral oil, dermal scores of 1 were noted in 1/20 test animals following the 24- and 48-hour scoring intervals. Dermal reactions in the remaining test, vehicle rechallenge control and the naive rechallenge control animals were limited to scores of 0 to +/-.
Following rechallenge with 10% w/w Alkanoic acid amide in USP mineral oil, dermal reactions were limited to scores of 0 to " following the 24- and 48-hour scoring intervals.
At challenge, dermal scores of 1 or greater were observed in 4/20 animals at both the 24-hour and the 48-hour scoring intervals.
At rechallenge, dermal scores of 1 or greater were observed in 1/20 animals (same concentration as challenge) or 0/20 animals (lower concentration than challenge) at both the 24-hour and the 48-hour scoring intervals.
No animals responded at both challenge and rechallenge.
Challenge controls:
Yes. A vehicle challenge control group and a vehicle rechallenge control group of five male and five females each received the vehicle for the induction dosing period.
Positive control substance(s):
yes
Remarks:
hexylcinnamaldehyde

Results and discussion

Positive control results:
The results of the HCA positive control study demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitizers.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: Not measured/tested
Hours after challenge:
0
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
not measured/tested
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
5% (induction)
1% (challenge)
No. with + reactions:
2
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
5% (induction)
2.5% (challenge)
No. with + reactions:
6
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
4
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
4
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test substance would not meet the classification requirements for skin sensitization.
Executive summary:

The dermal sensitization potential of EC 701 -204 -9 was evaluated in male and female Hartley-derived albino guinea pigs when administered by multiple topical applications. Ten male and ten female guinea pigs were topically treated with 75% test article concentration, once per week, for three consecutive weeks. In addition, each group contained a vehicle challenge control group and a vehicle rechallenge control group of five male and five females each that received the vehicle for the induction dosing period. Following a two-week rest period, a challenge was performed whereby the twenty test, ten vehicle challenge control and ten previously untreated naive challenge control guinea pigs were topically treated with 25% test article concentration. Challenge responses in the test animals were compared with those of the vehicle challenge control and the naive challenge control animals. Following a seven day rest period, a rechallenge was performed at 25% in which the twenty test, ten vehicle rechallenge control and ten previously untreated naive rechallenge control guinea pigs were topically treated with the appropriate test article concentration. Rechallenge responses in the test animals were compared to those of the vehicle rechallenge control and the naive rechallenge control animals. In addition, the rechallenge response of each animal was compared to its challenge response. Dermal responses of 1 or greater were noted in 4 of 20 animals following primary challenge with 25% test article. Dermal responses of 1 or greater were noted in 1 of 20 animals following rechallenge with 25% test article. Dermal responses of 1 or greater were not noted in any animal following rechallenge with 10% test article. Dermal responses of 1 or greater were not noted in any of the vehical controls. The results of the HCA positive control study demonstrated that a valid test was performed and indicated that the test design would detect potential contact sensitizers.

Since the dermal responses observed following primary challenge at 25% could not be replicated at subsequent rechallenges, the conclusion of the study is that EC 701 -204 -9 did not elicit a skin sensitization response under the conditions of this study.