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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:
2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
2006
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test
Justification for non-LLNA method:
An appropriate guinea pig maximisation test/Buehler test is available which would not justify conducting an additional LLNA due to animal welfare. Also according to“Guidance on information requirements and chemical safety assessment Chapter R.7a: Endpoint-specific guidance” (ECHA, 2008) any OECD method can be used for registration.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
In order to substantiate this evaluation, the Tecarn-Tecnologia Ambiental Ltda accredited before the Ministry of Agriculture and is holder of bio-safety certificates.
SMS samples were collected in CST´s processing plants. The crushed stone is from Brasitalia quarry, located in the municipality of Serra, Brasilia. Crushed stone samples were collected and prepared by the company Kaerne Engenharia Ltda. In compliance with the method defined in NBR 10.007.2007.

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino (no other information supplied)
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
sterile saline solution and the complete Freund adjuvant (FCA) in the proportion of 1:1, plus a topical application of the product (experimental group 1).
Challengeopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
sterile saline solution and the complete Freund adjuvant (FCA) in the proportion of 1:1, plus a topical application of the product (experimental group 1).
No. of animals per dose:
20 albino guinea pigs, adult and healthy were previously selected and accepted for the dermal sensitivity test.
The animals were divided into three groups (10 animales experimental groups) 2 control groups (each 5 animals).
Details on study design:
In sterile bandages, the control group 2 and the experimental group received the product, control group 1 sterile saline solution only, administrated under an occlusive patch on the previously shaved left side of each animal for 48 h, and repeated every 48 h for a total of 10 applications. An additional 1:1 mixture of sterile saline solution and FCA was intradermally injected to the animals of the control groups 1 and of the experimental group.
On day 24 after the start of the treatment, the last patch was removed. A consecutive waiting period of one week without treatment enabled the development of a potentially hyper-sensitized state of the animals. On day 36, in the beginning of the challenge period, the product was administered to the animals under occlusive patch on the shaved untreated (right) side. On day 38, the patches were removed and the skin was examined after 1 h, 6 h, and 24 h to identify erythema and edema.
Dermal sensitization was assessed by comparisons between the initial formation of edema and erythema and the reactions observed after the challenge period. The tested product was considered potentially sensitizing when the edema and erythema readings scores were higher in the experimental than in the control group.
Challenge controls:
challenge period 6 h
Positive control substance(s):
no

Results and discussion

Positive control results:
no

In vivo (non-LLNA)

Results
Reading:
other: result
Hours after challenge:
48
Group:
test group
Dose level:
max.
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
(none reproted) not sensitising
Remarks on result:
other: Reading: other: result. . Hours after challenge: 48.0. Group: test group. Dose level: max.. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: (none reproted) not sensitising.

Any other information on results incl. tables

not sensitizing

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Slags, steelmaking (SMS), and crushed stone from a quarry in Serra, Brasilia:
OECD 406 Buehler tests, Guinea pigs: not sensitizing
Executive summary:

The possible allergenic activities of slags, steelmaking (SMS) and crushed stones from a quarry in the vicinity of Serra, Brasilia, were tested according to the OECD TG 406 Skin Sensitisation Test.

For induction, 10 Guinea pigs were exposed to the wetted substance 10 times topical applications under occlusive dressing for 48 h. After a 7 day rest phase, the challenge phase consisted of a single topical application (48 h).

No visible cutaneous reactions and no intolerance reaction was recorded in the challenge phase, and no reaction was recorded in the negative controls.

Slags, steelmaking (SMS) and the crushed stone tested, are not

sensitising and do not need to be classified as skin sensitizers. No signal word and no hazard statement are required.