Registration Dossier

Administrative data

Description of key information

No data available on substance.  See discussion for data on analogues

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

There is no data available measured on the test substance itself " Pentadecane, 7-methylene mixed with 1-tetradecene, dimers and trimers, hydrogenated", which is a C28 -80H58 -162 saturated branched alphaolefin oligomer of number average molecular weight 443 (Mw=448) but data is available on four alphaolefin analogues based on oligomerised and hydrogenated 1-decene. These span a number average molecular weight of 287 -603 and whilst linear rather than branched are likely to behave similarly for these end points.

SKIN IRRITANCY

The table below indicates the results from the analogue substances:

 Analogue Mn  Primary skin irritation index

 Max irritation score

(erythema)

 Classification
 287 3.1   3  Irritant
 443  1.3  3  Not irritant
528   0.5  2  Not irritant
603   0.5  1  Not irritant

There is a clear trend of decreasing irritancy potential with molecular weight increase. Based on these results, the closest analogue is the one with similar molecular weight which would suggest that the dossier substance would be a mild skin irritant only. Quantitatively, these results involved using 0.5ml over one square inch of skin (6.25cm2), which is approximately 65mg/cm2. This can be deemed a NOAEL for skin irritation.

EYE IRRITANCY

The table below indicates the results from the analogue substances:

 Analogue Mn  Overall irritation score(Average of 24, 48, 72hrobservations)

Maximum score

in any one animal

at any time point

 Classification
 287  6  Not irritant
 443  1.8  4  Not irritant
528   0.33  2  Not irritant
603  1.4  4  Not irritant

Note: overall irritation score = (Degree of corneal opacityxareax5)+(Iris scorex5)+(erythema score+conjunctival score+swelling)x5. Maximum possible score is 110. Maximum score is maximum overall irritation score seen in any one animal.

No substance caused corneal effects or iritis. There was no clear trend with molecular weight, although there is some suggestion that the lowest molecular weight oligomer is slightly more irritating. Overall, the substances show very low irritating potential.

Based on these results, the closest analogue is the one with similar molecular weight which would suggest that it would be a mild eye irritant only.

RESPIRATORY IRRITATION

There is no data available but the results for skin and eye irritancy indicate a very low respiratory irritation potential

Justification for classification or non-classification

SKIN IRRITATION: Based on the data available from read across substances, the substance of interest is not likely to meet the criteria as a skin irritant either from the perspective of acute effects or time for them to disappear.

EYE IRRITATION: Based on the data available from read across substances, the substance of interest is not likely to meet the criteria as a eye irritant either from the perspective of acute effects or time for them to disappear.