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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 28 August 1985 and 4 October 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study conducted in accordance with a method similar to an existing guideline with some details not reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: U.S. 40 CFR Section 163.81-6 (b)(6)(ii) Federal Register August 22, 1978 and subsequently modified in accordance with the revised EPA Pesticide Assessment Guidelines of November 1982
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
Study conducted prior to regulatory guidelines

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction product of methylenebis(acrylamide) and (O,O)-diisooctyl dithiophosphoric acid
EC Number:
700-945-5
Molecular formula:
Complex UVCB substance
IUPAC Name:
Reaction product of methylenebis(acrylamide) and (O,O)-diisooctyl dithiophosphoric acid
Test material form:
other: Gold colored viscous liquid
Details on test material:
Description: Gold colored viscous liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
Animals (300 to 500 g) house and maintained in accordance with standards set forth in the Guide for the Care an Use of Laboratory Animals (DHEW Publication No. 8-23 and were acclimated 7 days prior to testing and individually identified by toe clipping. The animals were housed in stainless steel cages with elevated wire mess floors (3-5 animals per cage). Each cage was identified by a cage card. Husbandry conditions were as follows: Temperature 60 to 75 degrees C Relative Humidity 55+/_ 25% Light 12 hours light/dark cycle diet Wayne Guinea Pig Formula and tap water ad libitum.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
50% initially and then 25% on the remaining 8 days of induction
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
50% initially and then 25% on the remaining 8 days of induction
No. of animals per dose:
12
Details on study design:
Prior to initiation of the main study, a preliminary study was conducted at 50% and 25 % to determine the induction and challenge concentration to be used in the main study. Because no skin irritation was observed after 24 hours at either concentration, 50% was selected as the concentration to start the study. The test material as prepared was dosed at 0.5 ml.

In the induction phase of the main study, a group of 12 male albino guinea pigs was clipped over a wide area (and repeated as needed). a dose of 0.5 ml of the prepared test material at a 50% dilution was applied to the test site, covered with a guaze patch, and then covered with an impervious wrapping. Because irritation (barely perceptible and well-defined erythema) was observed at 24 hours following the first of nine days of dosing, the induction concentration for the remaing 8 application days for the induction and the challenge application were changed to 25%. After 6 hours following each daily induction dosing the patch was removed and the animals were allowed to rest for at least one day. Following the rest period another application was applied to the site using a fresh sample. After the ninth (final) application, the animals were allowed to rest 2 weeks. At the termination of the rest period a challenge application was applied to a different site from the original on each animal the skin reactions were then scored at at 24 and 48 hours following the challenge according to the method of Draize.
Challenge controls:
No Naive control; 12 animals for concurrent positive control
Positive control substance(s):
yes
Remarks:
1-chloro-2,4-dinitrobenzene 0.1% in 25% ethanol:0.9% saline

Results and discussion

Positive control results:
Erythema 24 hours: 8/12 with barely perceptable irritation (score = 1); 2/12 with well-definded erythema (score = 2). Erythema 48 hours: 4/12 with barely perceptable irritation (score = 1); 3/12 with well-definded erythema (score = 2). No edema was observed in any animal

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 12.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
12
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 12.0.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.15
No. with + reactions:
2
Total no. in group:
12
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.15. No with. + reactions: 2.0. Total no. in groups: 12.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1%
No. with + reactions:
3
Total no. in group:
12
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 3.0. Total no. in groups: 12.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on EU CLP Regulation No. 1272/2008 this product is not classified for skin sensitization.
Executive summary:

Prior to initiation of the main study, a preliminary study was conducted at 50% and 25 % to determine the induction and challenge concentration to be used in the main study. Because no skin irritation was observed after 24 hours at either concentration, 50% was selected as the concentration to start the study. The test material as prepared was dosed at 0.5 ml. In the induction phase of the main study, a group of 12 male albino guinea pigs was clipped over a wide area (and repeated as needed). a dose of 0.5 ml of the prepared test material at a 50% dilution was applied to the test site, covered with a gauze patch, and then covered with an impervious wrapping. Because irritation (barely perceptible and well-defined erythema) was observed at 24 hours following the first of nine days of dosing, the induction concentration for the remaing 8 application days for the induction and the challenge application were changed to 25%. After 6 hours following each daily induction dosing the patch was removed and the animals were allowed to rest for at least one day. Following the rest period another application was applied to the site using a fresh sample. After the ninth (final) application, the animals were allowed to rest 2 weeks. At the termination of the rest period a challenge application was applied to a different site from the original on each animal the skin reactions were then scored at at 24 and 48 hours following the challenge according to the method of Draize. No evidence of skin sensitization was observed. All scores at the 24 and 48 hour observation in the challenge phase were zero in all animals (0/12). Evidence of well-defined erythema (score = 2) was observed in 2/12 animals at 24 hours and 3/12 animals at 48 hours in the challenge phase with the 0.1% concurrent positive control indicating that the test was valid. Based on EU CLP Regulation No. 1272/2008 this product is not classified for skin sensitisation.