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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation, other
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1998-03-31 to 1999-04-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well documented OECD guideline study performed under GLP.
Justification for type of information:
REPORTING FORMAT FOR THE CATEGORY APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH: The hypothesis is that properties are likely to be similar or follow a similar pattern because of the presence of a common metal ion, in this case tungstate.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES):
Source: Tungsten Metal
Target: Tungsten Disulphide


3. CATEGORY APPROACH JUSTIFICATION: See Annex 1 in CSR

4. DATA MATRIX: See Annex 1 in CSR
Cross-reference
Reason / purpose:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A 1999 guinea pig sensitisation study was available of good quality. Therefore, there is no need to conduct a LLNA study as the guinea pig sensitisation study scientifically fulfills the endpoint. The OECD 406 method provides sensitisation information likely to arise from exposure to test substance via intradermical injection and/or epidermical application to guinea pigs. The guinea pig sensitisation test detects chemicals with moderate to strong sensitisation potential, as well as those with relatively weak sensitisation potential. In such methods activity is measured as a function of challenge-induced dermal hypersensitivity reactions elicited in test animals compared with controls. In addition, guinea pigs have been the animal of choice for predictive sensitisation tests for several decades (way before the LLNA became the test of choice).
The existing guinea pig data submitted here is of good quality as clear results are presented in this robust summary and test methodology followed OECD 406 guidelines, and conducted under GLP. This study it is considered acceptable according to page 266 in ECHA's Chapter r7a on Guidance on Information Requirements and Chemical Safety Assessment.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tungsten Metal powder
- Physical state: Grey powder
- Analytical purity: >99%

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: 4 to 7 wks
- Weight at study initiation: 371 to 436 g
- Housing: In groups of five in suspended metal cages with wire mesh floors.
- Diet: ad libitum Vitamin C enriched (Harlan Teklad 9600 FD2 SQC). Hay was given thrice weekly.
- Water: ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 25.5
- Humidity (%): 37 to 66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12


IN-LIFE DATES: From: 1998-03-31 to: 1998-05-01

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of ill health or toxicity were recorded.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded..
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

RESULTS

Dermal reactions seen following the induction:

- Intradermal injections:

Necrosis was recorded at most sites receiving Freund's Complete Adjuvant in both test and control animals.

Slight irritation was seen in most test animals at sites receiving Tungsten metal powder (20% w/v) in sterile water. No irritation was observed in control animals receiving sterile water for injection.

Topical application:

Slight erythema was observed in most test animals following topical application with Tungsten metal powder, 70% w/v in distilled water. Slight erythema was also seen in most of the control guinea-pigs after topical application of distilled water alone.

- Dermal reactions elicited by the challenge applications:

No dermal reactions were seen in any of the test or control animals.

BODYWEIGHT

Bodyweight increases were recorded for all guinea pigs over the period of the study.

CLINICAL SIGNS

No signs of ill health or toxicity were recorded.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under conditions of this study, Tungsten metal powder did not produce evidence of skin sensitization (delayed contact hypersensitivity).
Executive summary:

No skin sensitisation data of sufficient quality are available for tungsten disulphide (target substance). However, skin sensitisation data are available for tungsten metal (source substance), which will be used for reading across. Due to similar water solubility and toxicity for the target substance compared to the source substance, the resulting read across from the source substance to the target substance is appropriate. In addition, read across is appropriate because the classification and labelling is similar for the source substance than the target substance, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, lower for the source substance. For more details, refer to the read-across category approach included in the Category section of this IUCLID submission and/or as an Annex in the CSR.