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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:
August 04, 1998 - September 05, 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Also according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
(1996)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study was performed before the LLNA was existed as an OECD guideline method.

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium O,O-diisobutyl phosphorothioate
EC Number:
610-992-2
Cas Number:
53378-52-2
Molecular formula:
C8 H18 O3 P S . Na
IUPAC Name:
Sodium O,O-diisobutyl phosphorothioate
Test material form:
other: grease-like solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): AERO® 6697 Promoter
- Name: Sodium diisobutyl monothiophoshate
- CAS: 53378-52-2
- Molecular formula: C8H18O3PS.Na
- Molecular weight: 248.26
- Storage condition of test material: not indicated in the study report
- Batch no.: 294

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: D. Hall, Newchurch, Staffs, UK
- Age at study initiation: 5 to 8 weeks
- Weight at study initiation: 347 - 423 g
- Housing: The animals were housed in groups of five is suspended metal cages with wire mesh floors.
- Diet: Free access to vitamin C enriched guinea-pig diet (Harlan Teklad 9600 FD2 SQC). Hay was given thrice weekly.
- Water: Free access to water.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 30
- Humidity (%): 40 to 68
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction: 7.5% for the intradermal induction and 50% for the epidermal induction (v/v in distilled water)
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at challenge: 10 and 5% v/v in distilled water
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10
Details on study design:
RANGE FINDING TESTS (6 animals)

The animals for the topical irritancy investigations were pre-treated with an intradermal injection of Freund's complete adjuvant, 50:50 with water for irrigation, approximately one week prior to the start of the preliminary investigations.

Based on the results of the preliminary investigations, the following concentrations were selected:
Induction intradermal injection: 7.5%, this was the highest concentration that caused irritation but did not adversely affect the animals.
Induction topical application: 50%, this was the highest concentration that produced some irritation but did not adversely affect the animals.
Topical challenge: 10 and 5%, from preliminary investigations 10% was the highest concentration not giving rise to irritating effects.

MAIN STUDY

A. INDUCTION EXPOSURE
- No. of exposures: 2

1) Intradermal injections on day 1:
- Concentration: 7.5%
- Site: dorsal skin on the scapular region.
Three pairs of intradermal injections:
1) 0.1 mL: FCA (50% in water for irrigation)
2) 0.1 mL: test substance at a 7.5% concentration (control animals: 0.1 mL corn oil)
3) 0.1 mL: test substance at a 7.5% concentration in a 50:50 mixture of FCA and water for irrigation.

2)Topical application on day 8:
- Concentration: 50% in distiiled water
- Amount: 0.4 mL (control animals: 0.4 mL of distilled water)
- Area: approximately 8 cm^2
- Exposure period: 48 hours (occlusive)
- Readings: scores were rated directly after patch removal

B. CHALLENGE EXPOSURE (all animals, with the 10 and 5% test substance in distilled water)
- Day of challenge: day 22
- Exposure period: 24 hours (occlusive)
- Site: left flank
- Amount: 0.2 mL
- Readings: scores were rated 24 and 48 hours after patch removal
Challenge controls:
Not applicable.
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole (June/July 1998)

Results and discussion

Positive control results:
The latest reliability check (performed less than 6 months ago) produced evidence of skin sensitisation in all of the animals.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of ill health or toxicity were recorded.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of ill health or toxicity were recorded.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of ill health or toxicity were recorded.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of ill health or toxicity were recorded.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of ill health or toxicity were recorded.
Reading:
other: Not specified
Group:
positive control
Dose level:
40d and 83.3%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Remarks:
The latest reliability check (performed less than 6 months ago) produced evidence of skin sensitisation in all of the animals.

Any other information on results incl. tables

No signs of ill health or toxicity were recorded. Bodyweight increases were recorded for all animals over the period of the study.

Induction:

Intradermal injections: Necrosis was recorded at sites receiving FCA in test and control animals. Slight irritation was seen in test animals at sites receiving the 7.5% test substance and no irritation was observed in most animal receiving water.

Topical application: No erythema was observed in most test animals following topical application. No erythema was seen in the control animals.

Challenge:

There were no dermal reactions seen in any of the test or control animals that were considered to be related to treatment, therefore all twenty test animals gave negative responses. Slight localised erythema was noted for one control and one test animal and was considered to represent background irritation.

In the reliability test (performed in June/July 1998), evidence of skin sensitisation was shown in all of the ten animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this adjuvant type guinea pig test method for skin sensitisation according to OECD 406 guideline and GLP principles, Aero® 6697 Promoter did not produce evidence of skin sensitization in any of the twenty test animals.
Executive summary:

Assessment of the skin sensitization potential of Aero® 6697 Promoter, a 50% solution in water, using the guinea-pig, according to OECD 406 guideline and GLP principles. No signs of ill health or toxicity were recorded. Bodyweight increases were recorded for all animals over the period of the study.

Induction:

Intradermal injections: Necrosis was recorded at sites receiving FCA in test and control animals. Slight irritation was seen in test animals at sites receiving the 7.5% test substance and no irritation was observed in most animal receiving water.

Topical application: No erythema was observed in most test animals following topical application. No erythema was seen in the control animals.

Challenge:

There were no dermal reactions seen in any of the test or control animals that were considered to be related to treatment, therefore all twenty test animals gave negative responses. Slight localised erythema was noted for one control and one test animal and was considered to represent background irritation.

Based on the results, Aero® 6697 Promoter, a 50% solution in water, did not produce evidence of skin sensitization in any of the twenty test animals.